MedDataX Logo

Trial Outcomes & Findings for Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients (NCT NCT02228096)

NCT ID: NCT02228096

Last Updated: 2020-11-23

Results Overview

ORR is defined as the percentage of participants with a best overall disease response of complete remission (CR) or Complete remission with incomplete blood count recovery (CRi), where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until the start of new anticancer therapy. Best response was assigned in the following order: CR, CRi, CR or CRi with residual mediastinal disease, No response and Unknown.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

75 participants

Primary outcome timeframe

within 6 months after CTL019 infusion

Results posted on

2020-11-23

Participant Flow

Patients were recruited between 14-Aug-2014 (FPFV) and 22-Sep-2017 (LPFV). At the time of LPLV (24-May-2019), the sponsor had decided to transfer all ongoing patients to a separate long-term follow-up study to complete the planned 15 years of follow-up. These patients are designated with the reason for discontinuation as "terminated by sponsor".

"Enrolled" means all eligibility criteria were met and apheresis was accepted by the manufacturing facility. Patients could discontinue the trial after enrollment and prior to tisagenlecleucel infusion. Although 75 patients were enrolled, only 64 were infused as 11 discontinued prior to infusion.

Participant milestones

Participant milestones
Measure
Tisagenlecleucel (CTL019) - All Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Overall Study
STARTED
75
Overall Study
Enrolled Into Long-term f/u Protocol
31
Overall Study
Enrolled But Not Infused
11
Overall Study
Enrolled and Infused
64
Overall Study
COMPLETED
4
Overall Study
NOT COMPLETED
71

Reasons for withdrawal

Reasons for withdrawal
Measure
Tisagenlecleucel (CTL019) - All Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Overall Study
Study terminated by Sponsor
24
Overall Study
Lack of Efficacy
18
Overall Study
Death
12
Overall Study
Physician Decision
3
Overall Study
Subject/guardian decision
2
Overall Study
New therapy for study indication
1
Overall Study
Enrolled, not infused
11

Baseline Characteristics

FAS = All subjects who received an infusion of tisagenlecleucel

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Tisagenlecleucel (CTL019) - All Participants
n=64 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Not Infused
n=11 Participants
Pediatric patients with r/r B-cell who were enrolled in the study but not infused with tisagenlecleucel
Total
n=75 Participants
Total of all reporting groups
Age, Continuous
12.4 Years
STANDARD_DEVIATION 5.16 • n=64 Participants
15.2 Years
STANDARD_DEVIATION 5.44 • n=11 Participants
12.8 Years
STANDARD_DEVIATION 5.26 • n=75 Participants
Sex: Female, Male
Female
34 Participants
n=64 Participants
1 Participants
n=11 Participants
35 Participants
n=75 Participants
Sex: Female, Male
Male
30 Participants
n=64 Participants
10 Participants
n=11 Participants
40 Participants
n=75 Participants
Race/Ethnicity, Customized
White
52 participants
n=64 Participants
8 participants
n=11 Participants
60 participants
n=75 Participants
Race/Ethnicity, Customized
Asian
5 participants
n=64 Participants
1 participants
n=11 Participants
6 participants
n=75 Participants
Race/Ethnicity, Customized
Other
7 participants
n=64 Participants
2 participants
n=11 Participants
9 participants
n=75 Participants
Weight
43.7 kg
STANDARD_DEVIATION 20.10 • n=64 Participants
86.2 kg
STANDARD_DEVIATION 41.52 • n=11 Participants
47.3 kg
STANDARD_DEVIATION 25.25 • n=75 Participants
Karnofsky/Lansky performance status
100
18 Participants
n=64 Participants • FAS = All subjects who received an infusion of tisagenlecleucel
—
18 Participants
n=64 Participants • FAS = All subjects who received an infusion of tisagenlecleucel
Karnofsky/Lansky performance status
90
28 Participants
n=64 Participants • FAS = All subjects who received an infusion of tisagenlecleucel
—
28 Participants
n=64 Participants • FAS = All subjects who received an infusion of tisagenlecleucel
Karnofsky/Lansky performance status
80
13 Participants
n=64 Participants • FAS = All subjects who received an infusion of tisagenlecleucel
—
13 Participants
n=64 Participants • FAS = All subjects who received an infusion of tisagenlecleucel
Karnofsky/Lansky performance status
70
2 Participants
n=64 Participants • FAS = All subjects who received an infusion of tisagenlecleucel
—
2 Participants
n=64 Participants • FAS = All subjects who received an infusion of tisagenlecleucel
Karnofsky/Lansky performance status
60
1 Participants
n=64 Participants • FAS = All subjects who received an infusion of tisagenlecleucel
—
1 Participants
n=64 Participants • FAS = All subjects who received an infusion of tisagenlecleucel
Karnofsky/Lansky performance status
50
2 Participants
n=64 Participants • FAS = All subjects who received an infusion of tisagenlecleucel
—
2 Participants
n=64 Participants • FAS = All subjects who received an infusion of tisagenlecleucel
Karnofsky/Lansky performance status
less than 50
0 Participants
n=64 Participants • FAS = All subjects who received an infusion of tisagenlecleucel
—
0 Participants
n=64 Participants • FAS = All subjects who received an infusion of tisagenlecleucel

PRIMARY outcome

Timeframe: within 6 months after CTL019 infusion

Population: Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS

ORR is defined as the percentage of participants with a best overall disease response of complete remission (CR) or Complete remission with incomplete blood count recovery (CRi), where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until the start of new anticancer therapy. Best response was assigned in the following order: CR, CRi, CR or CRi with residual mediastinal disease, No response and Unknown.

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=64 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Overall Remission Rate (ORR) Per Independent Review Committee (IRC) (for ALL Participants)
70.3 Percentage of participants
Interval 57.6 to 81.1
—
—
—
—

PRIMARY outcome

Timeframe: 6 months after CTL019

Population: Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS. No patients with Lymphoblastic Lymphoma were enrolled in this trial, hence there is no data to report.

Overall Remission Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and cerebrospinal fluid (CSF). This primary endpoint was based on the local investigator assessment. No participants with lymphoblastic lymphoma were infused in this study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 6

Population: Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS.

Evaluate the percentage of participants who achieved CR or CRi at Month 6 without SCT between tisagenlecleucel infusion and Month 6 response assessment.

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=64 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Percentage of Participants With Clinical Response Without Stem Cell Transplantation (SCT) at Month 6 - Per IRC Assessment
53.1 Percentage of participants
Interval 40.2 to 65.7
—
—
—
—

SECONDARY outcome

Timeframe: prior to Month 6

Population: Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS.

Evaluate the percentage of subjects who achieved CR or CRi and then proceeded to SCT while in remission prior to Month 6 response assessment.

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=64 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Percentage of Subjects Who Achieved CR or CRi and Then Proceeded to SCT While in Remission Prior to Month 6 Response - Per IRC Assessment
7.8 Percentage of participants
Interval 2.6 to 17.3
—
—
—
—

SECONDARY outcome

Timeframe: From CR or CRi to relapse or death up to 60 months

Population: Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS.

DOR is the time from achievement of CR or CRi, whichever occurs first, to relapse or death due to ALL

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=64 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=64 Participants
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Duration of Remission (DOR) Per Local and IRC Assessment
NA months
Interval 13.6 to
N/A = median DOR was not reached as there were not enough participants with DOR events
NA months
Interval 13.6 to
N/A = median DOR was not reached as there were not enough participants with DOR events
—
—
—

SECONDARY outcome

Timeframe: within 6 months

Population: Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS.

Percentage of participants with best overall response (BOR) of CR or CRi with MRD negative bone marrow status 6 months after CTL019 infusion among all participants who achieved CR or CRi per Local Investigator \& IRC assessment

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=64 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=64 Participants
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Percentage of Participants With CR or CRi With Minimum Residual Disease (MRD) Negative Bone Marrow 6 Months After CTL019 Infusion
67.2 Percentage of participants
Interval 54.3 to 78.4
67.2 Percentage of participants
Interval 54.3 to 78.4
—
—
—

SECONDARY outcome

Timeframe: 60 Months

Population: Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS.

RFS is the time from achievement of CR or CRi whichever occurs first to relapse or death due to any cause during CR or CRi.

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=45 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=45 Participants
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Relapse-free Survival (RFS) for Responders Per Local and IRC Assessment
NA months
Interval 13.6 to
N/A = median RFS was not reached as there were not enough participants with RFS events
NA months
Interval 13.6 to
N/A = median RFS was not reached as there were not enough participants with RFS events
—
—
—

SECONDARY outcome

Timeframe: 60 Months

Population: FAS: All subjects who received an infusion of CTL019

EFS is the time from date of CTL019 infusion to the earliest of death, relapse or treatment failure. Treatment failure is defined as "no response" in the study and discontinuation from the study due to any of the following reasons: death, AE, lack of efficacy, new anticancer therapy.

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=64 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=64 Participants
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Event-free Survival (EFS) Per Local and IRC Assessment
15.6 months
Interval 6.4 to
N/A = not estimable because there were not enough participants who had an EFS event to estimate the upper limit of the median EFS
15.6 months
Interval 6.4 to
N/A = not estimable because there were not enough participants who had an EFS event to estimate the upper limit of the median EFS
—
—
—

SECONDARY outcome

Timeframe: 60 Months

Population: FAS: All subjects who received an infusion of CTL019

OS is the time from date of CTL019 infusion to the date of death due to any reason

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=64 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Overall Survival (OS)
29.9 months
Interval 15.1 to 42.4
—
—
—
—

SECONDARY outcome

Timeframe: Day 28

Population: Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS. BM MRD were only collected and measured only within responders.

Percentage of participants attaining CR or CRi with MRD negative bone marrow status at Day 28 +/- 4 days after CTL019 infusion per Local Investigator and IRC assessment. BM MRD were only collected and measured only within responders.

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=64 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=64 Participants
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Secondary Outcome: Percentage of Participants Attaining CR or CRi With MRD Negative Bone Marrow Status at Day 28 +/- 4 Days After CTL019 Infusion
With BM MRD -ve: i.e. MRD% < 0.01%
71.9 Percentage of participants
Interval 59.2 to 82.4
71.9 Percentage of participants
Interval 59.2 to 82.4
—
—
—
Secondary Outcome: Percentage of Participants Attaining CR or CRi With MRD Negative Bone Marrow Status at Day 28 +/- 4 Days After CTL019 Infusion
With BM 0.01% <= MRD% < 5%
1.6 Percentage of participants
N/A: only 1 participant with BM MRD to calculate meaningful confidence interval (CI)
1.6 Percentage of participants
N/A: only 1 participant with BM MRD to calculate meaningful confidence interval (CI)
—
—
—
Secondary Outcome: Percentage of Participants Attaining CR or CRi With MRD Negative Bone Marrow Status at Day 28 +/- 4 Days After CTL019 Infusion
With BM MRD% >= 5%
1.6 Percentage of participants
N/A: only 1 participant with BM MRD to calculate meaningful CI
1.6 Percentage of participants
N/A: only 1 participant with BM MRD to calculate meaningful CI
—
—
—
Secondary Outcome: Percentage of Participants Attaining CR or CRi With MRD Negative Bone Marrow Status at Day 28 +/- 4 Days After CTL019 Infusion
BM MRD not available
6.3 Percentage of participants
N/A: few participants with BM MRD to provide meaningful CI
6.3 Percentage of participants
N/A: few participants with BM MRD to provide meaningful CI
—
—
—

SECONDARY outcome

Timeframe: Enrollment; D1; D4; D7; D11; D14; D21; D28; M3; M6; M9, M12; M18; M24, M30, M36, M42, M48 for transgene levels in blood; Screening, D28, M3, M6 for transgene levels in bone marrow

Population: Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data

Characterize the in vivo cellular pharmacokinetic (PK) profile (levels,persistence, trafficking) of CTL019 cells in target tissues

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=52 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=6 Participants
Pediatric participants with r/r B-cell ALL
Unknown
n=6 Participants
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
Screening: Bone marrow (BM)
NA copies/ug DNA
Geometric Coefficient of Variation NA
N/A = No CTL019 was infused at screening
NA copies/ug DNA
Geometric Coefficient of Variation NA
N/A = No CTL019 was infused at screening
NA copies/ug DNA
Geometric Coefficient of Variation NA
N/A = No CTL019 was infused at screening
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
D28 BM
646 copies/ug DNA
Geometric Coefficient of Variation 1009.7
969 copies/ug DNA
Geometric Coefficient of Variation 166.8
615 copies/ug DNA
Geometric Coefficient of Variation 4763885.9
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
Enrollment blood
NA copies/ug DNA
Geometric Coefficient of Variation NA
N/A: No CTL019 was infused at the enrollment
NA copies/ug DNA
Geometric Coefficient of Variation NA
N/A: No CTL019 was infused at the enrollment
NA copies/ug DNA
Geometric Coefficient of Variation NA
N/A: No CTL019 was infused at the enrollment
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
Day 1 (D1): blood
3680 copies/ug DNA
Geometric Coefficient of Variation 344.3
3190 copies/ug DNA
Geometric Coefficient of Variation 348.6
2440 copies/ug DNA
Geometric Coefficient of Variation 220.6
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
D4: blood
234 copies/ug DNA
Geometric Coefficient of Variation 197.8
48.8 copies/ug DNA
Geometric Coefficient of Variation 282.4
88.0 copies/ug DNA
Geometric Coefficient of Variation 71.0
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
D7: blood
4460 copies/ug DNA
Geometric Coefficient of Variation 616.2
231 copies/ug DNA
Geometric Coefficient of Variation 499.1
402 copies/ug DNA
Geometric Coefficient of Variation 114.7
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
D11: blood
21200 copies/ug DNA
Geometric Coefficient of Variation 262.3
423 copies/ug DNA
Geometric Coefficient of Variation 52.7
1920 copies/ug DNA
Geometric Coefficient of Variation 8318.1
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
D14: blood
12500 copies/ug DNA
Geometric Coefficient of Variation 292.1
1600 copies/ug DNA
Geometric Coefficient of Variation 337.1
42835.8 copies/ug DNA
Geometric Coefficient of Variation 9060
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
D21: blood
3720 copies/ug DNA
Geometric Coefficient of Variation 480.5
7750 copies/ug DNA
Geometric Coefficient of Variation 334.5
1050 copies/ug DNA
Geometric Coefficient of Variation 220743.9
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
D28: blood
1360 copies/ug DNA
Geometric Coefficient of Variation 650.3
2770 copies/ug DNA
Geometric Coefficient of Variation 684.8
515 copies/ug DNA
Geometric Coefficient of Variation 244650713.9
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
Month 3 (M3): blood
220 copies/ug DNA
Geometric Coefficient of Variation 224.3
690 copies/ug DNA
Geometric Coefficient of Variation NA
N/A = not estimable because too few participants to calculate Geometric CV
564 copies/ug DNA
Geometric Coefficient of Variation NA
N/A = not estimable because too few participants to calculate Geometric CV
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
Month M6: blood
146 copies/ug DNA
Geometric Coefficient of Variation 157.5
NA copies/ug DNA
Geometric Coefficient of Variation NA
N/A = not estimable because too few participants to calculate Geometric CV; also, the geometric mean was not applicable for NR group at Month 6 as the arithmetic mean was zero
127 copies/ug DNA
Geometric Coefficient of Variation NA
N/A = not estimable because too few participants to calculate Geometric CV
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
Month M9: blood
117 copies/ug DNA
Geometric Coefficient of Variation 179.3
—
—
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
Month M12: blood
113 copies/ug DNA
Geometric Coefficient of Variation 312.4
—
—
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
Month M18: blood
87.2 copies/ug DNA
Geometric Coefficient of Variation 200.3
—
—
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
Month M24: blood
92.7 copies/ug DNA
Geometric Coefficient of Variation 160.5
—
—
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
Month M30: blood
59.9 copies/ug DNA
Geometric Coefficient of Variation 150.0
—
—
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
Month M36: blood
10.7 copies/ug DNA
Geometric Coefficient of Variation 19.9
—
—
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
Month M42: blood
35.3 copies/ug DNA
Geometric Coefficient of Variation NA
N/A = not estimable because too few participants to calculate Geometric CV
—
—
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
Month M48: blood
NA copies/ug DNA
Geometric Coefficient of Variation NA
NA = geometric mean is not estimable because the CTL019 transgene level for the only one patient is 0.
—
—
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
M3 BM
179 copies/ug DNA
Geometric Coefficient of Variation 182.5
—
542 copies/ug DNA
Geometric Coefficient of Variation NA
N/A = not estimable because too few participants to calculate Geometric CV
—
—
CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
M6 BM
133 copies/ug DNA
Geometric Coefficient of Variation 121.7
35.3 copies/ug DNA
Geometric Coefficient of Variation NA
N/A = not estimable because too few participants to calculate Geometric CV
—
—
—

SECONDARY outcome

Timeframe: Baseline; Day 14; Day 28; Month 3; Month 6; Month 12; Month 24, Month 36

Population: Safety set: All subjects who received an infusion of tisagenlecleucel

Humoral immunogenicity was measured by anti-CTL019 antibodies in human serum using a flow cytometry method. (Prevalence and incidence of immunogenicity to CTL019)

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=52 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=6 Participants
Pediatric participants with r/r B-cell ALL
Unknown
n=6 Participants
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Humoral Immunogenicity Interpretation by Day 28 Disease Response Per IRC (Anti-CTL019 Antibodies)
Baseline: Positive
67.3 Percentage of participants
66.7 Percentage of participants
83.3 Percentage of participants
—
—
Humoral Immunogenicity Interpretation by Day 28 Disease Response Per IRC (Anti-CTL019 Antibodies)
Day 14: Positive
84.6 Percentage of participants
100 Percentage of participants
83.3 Percentage of participants
—
—
Humoral Immunogenicity Interpretation by Day 28 Disease Response Per IRC (Anti-CTL019 Antibodies)
Day 28: Positive
80.8 Percentage of participants
100 Percentage of participants
50.0 Percentage of participants
—
—
Humoral Immunogenicity Interpretation by Day 28 Disease Response Per IRC (Anti-CTL019 Antibodies)
Month 3: Positive
75.0 Percentage of participants
16.7 Percentage of participants
33.3 Percentage of participants
—
—
Humoral Immunogenicity Interpretation by Day 28 Disease Response Per IRC (Anti-CTL019 Antibodies)
Month 6: Positive
63.5 Percentage of participants
16.7 Percentage of participants
16.7 Percentage of participants
—
—
Humoral Immunogenicity Interpretation by Day 28 Disease Response Per IRC (Anti-CTL019 Antibodies)
Month 12: Positive
46.2 Percentage of participants
0 Percentage of participants
0 Percentage of participants
—
—
Humoral Immunogenicity Interpretation by Day 28 Disease Response Per IRC (Anti-CTL019 Antibodies)
Month 24: Positive
11.5 Percentage of participants
0 Percentage of participants
0 Percentage of participants
—
—
Humoral Immunogenicity Interpretation by Day 28 Disease Response Per IRC (Anti-CTL019 Antibodies)
Month 36: Positive
9.6 Percentage of participants
0 Percentage of participants
0 Percentage of participants
—
—

SECONDARY outcome

Timeframe: Within 6 months

Population: EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 12 having a low bone marrow tumor burden at enrollment.

ORR within 6 months after infusion of CTL019 per Local \& IRC assessment by baseline bone marrow tumor burden presence.

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=12 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=12 Participants
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
ORR by Low Baseline Bone Marrow Burden Within 6 Months Post CTL019 Infusion
83.3 percentage of participants
Interval 51.6 to 97.9
83.3 percentage of participants
Interval 51.6 to 97.9
—
—
—

SECONDARY outcome

Timeframe: Within 6 months

Population: EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 30 having a high bone marrow tumor burden at enrollment

ORR within 6 months after infusion of CTL019 per Local Investigator \& IRC assessment by high baseline bone marrow tumor burden presence.

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=30 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=30 Participants
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
ORR by High Baseline Bone Marrow Burden Within 6 Months Post CTL019 Infusion
63.3 percentage of participants
Interval 43.9 to 80.1
63.3 percentage of participants
Interval 43.9 to 80.1
—
—
—

SECONDARY outcome

Timeframe: Within 6 months

Population: EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 2 participants having a baseline extramedullary presence.

ORR within 6 months after infusion of CTL019 per Local Investigator \& IRC assessment by baseline extramedullary disease presence of Yes.

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=2 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=2 Participants
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
ORR by Baseline Extramedullary Disease Presence of Yes Within 6 Months Post CTL019 Infusion
100 percentage of participants
N/A: no confidence interval for 100% response
100 percentage of participants
N/A: no confidence interval for 100% response
—
—
—

SECONDARY outcome

Timeframe: Within 6 months

Population: EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 40 participants having no baseline extramedullary presence.

ORR within 6 months after infusion of CTL019 per Local Investigator \& IRC assessment by baseline extramedullary disease presence of No.

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=40 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=40 Participants
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
ORR by Baseline Extramedullary Disease Presence of No Within 6 Months Post CTL019 Infusion
67.5 percentage of participants
Interval 50.9 to 81.4
67.5 percentage of participants
Interval 50.9 to 81.4
—
—
—

SECONDARY outcome

Timeframe: Within 6 months

Population: Efficacy Analysis Set: A subset of FAS treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on cut-off date of 6-Oct-2017, with only 42 participants and 30 having a high baseline bone marrow tumor burden. BM MRD were collected and measured only within responders

BM MRD status was by Local Investigator and IRC assessment within 6 months after infusion of CTL019 by baseline bone marrow tumor burden. BM MRD were collected and measured only within responders.

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=30 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=30 Participants
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Bone Marrow (BM) Minimum Residual Disease (MRD) Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by High Baseline Bone Marrow Tumor Burden
Had BOR of CR/CRi with BM MRD -ve (MRD%< 0.01%)
56.7 percentage of participants
Interval 37.4 to 74.5
56.7 percentage of participants
Interval 37.4 to 74.5
—
—
—
Bone Marrow (BM) Minimum Residual Disease (MRD) Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by High Baseline Bone Marrow Tumor Burden
Had BOR of CR/CRi with BM 0.01% <= MRD% < 5%
6.7 percentage of participants
N/A = too few participants to calculate a meaningful CI
6.7 percentage of participants
N/A = too few participants to calculate a meaningful CI
—
—
—

SECONDARY outcome

Timeframe: Within 6 months

Population: Efficacy Analysis Set: A subset of FAS treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on cut-off date of 6-Oct-2017, with only 42 participants and 12 having a high baseline bone marrow tumor burden. BM MRD were collected and measured only within responders

BM MRD status was per Local Investigator and IRC assessment within 6 months after infusion of CTL019 by low baseline bone marrow tumor burden. BM MRD were collected and measured only within responders.

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=12 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=12 Participants
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Bone Marrow MRD Status Was by Flow Cytometry Within 6 Months Post CTL019 Infusion by Low Baseline Bone Marrow Tumor Burden
83.3 percentage of participants
Interval 51.6 to 97.9
83.3 percentage of participants
Interval 51.6 to 97.9
—
—
—

SECONDARY outcome

Timeframe: Within 6 months

Population: Efficacy Analysis Set: A subset of FAS treated with CTL019 at least 6 months prior to the clinical data cutoff. FAS: All subjects who received an infusion of CTL019. Data is based on cut-off date of 6-Oct-2017, with only 42 participants \& 2 having a BL extramedullary disease presence of Yes. BM MRD were collected \& measured only within responders.

BM MRD status was by Local Investigator and IRC assessment within 6 months after infusion pf CTL019 by baseline extramedullary disease presence of Yes. BM MRD were collected and measured only within responders.

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=2 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=2 Participants
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Bone Marrow MRD Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by Baseline Extramedullary Disease Presence: Yes
100 percentage of participants
Interval 15.8 to 100.0
100 percentage of participants
Interval 15.8 to 100.0
—
—
—

SECONDARY outcome

Timeframe: Within 6 months

Population: Efficacy Analysis Set: A subset of FAS treated with CTL019 at least 6 months prior to the clinical data cutoff. FAS: All subjects who received an infusion of CTL019. Data is based on cut-off date of 6-Oct-2017, with only 42 participants \& 40 having a BL extramedullary disease presence of No. BM MRD were collected \& measured only within responders.

BM MRD status WAS per Local Investigator and IRC assessment within 6 months after infusion pf CTL019 by baseline extramedullary disease presence of No. BM MRD were collected and measured only within responders.

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=40 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=40 Participants
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Bone Marrow MRD Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by Baseline Extramedullary Disease Presence: No
With BM MRD -ve (MRD%< 0.01%)
62.5 percentage of participants
Interval 45.8 to 77.3
62.5 percentage of participants
Interval 45.8 to 77.3
—
—
—
Bone Marrow MRD Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by Baseline Extramedullary Disease Presence: No
With bone marrow 0.01% <= MRD% < 5%
5.0 percentage of participants
N/A = too few participants to calculate CI
5.0 percentage of participants
N/A = too few participants to calculate CI
—
—
—

SECONDARY outcome

Timeframe: Within 6 months

Population: EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 12 having a low baseline marrow tumor burden

DoR per Local Investigator \& IRC assessment by low baseline marrow tumor burden

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=12 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=12 Participants
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Duration of Remission (DoR) Censoring Hematopoietic Stem Cell Transplantation (HSCT) by Low Baseline Bone Marrow Tumor Burden
NA months
Interval 5.4 to
N/A = median DoR was not reached as there were not enough participants with DoR events
NA months
Interval 5.4 to
N/A = median DoR was not reached as there were not enough participants with DoR events
—
—
—

SECONDARY outcome

Timeframe: Within 6 months

Population: EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 30 having a high baseline marrow tumor burden

DoR per Local Investigator \& IRC assessment by high baseline bone marrow tumor burden

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=30 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=30 Participants
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Duration of Remission (DoR) Censoring HSCT by High Baseline Bone Marrow Tumor Burden
NA months
Interval 5.3 to
N/A = median DoR was not reached as there were not enough participants with DoR events
NA months
Interval 5.3 to
N/A = median DoR was not reached as there were not enough participants with DoR events
—
—
—

SECONDARY outcome

Timeframe: Within 6 months

Population: EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 2 having a baseline extramedullary disease presence of Yes

DoR per Local Investigator \& IRC assessment by baseline extramedullary disease presence of Yes.

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=2 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=2 Participants
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Duration of Remission (DoR) Censoring HSCT by Baseline Extramedullary Disease Presence: Yes
NA months
Interval 3.4 to
N/A = median DoR was not reached as there were not enough participants with D0R events
NA months
Interval 3.4 to
N/A = median DoR was not reached as there were not enough participants with DoR events
—
—
—

SECONDARY outcome

Timeframe: Within 6 months

Population: EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 40 having a baseline extramedullary disease presence of No

DoR per Local Investigator \& IRC assessment by baseline extramedullary disease presence of No

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=40 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=40 Participants
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Duration of Remission (DoR) Censoring HSCT by Baseline Extramedullary Disease Presence: No
NA months
Interval 5.9 to
N/A = median DOR was not reached as there were not enough participants with DOR events
NA months
Interval 5.9 to
N/A = median DOR was not reached as there were not enough participants with DOR events
—
—
—

SECONDARY outcome

Timeframe: Baseline; Day 14; Day 28; Month 3; Month 6; Month 12; Month 24, Month 36

Population: Safety set: All subjects who received an infusion of tisagenlecleucel

Activation of T cells in PBMC collected from subjects in response to mCAR19 -derived peptides was used to assess the cellular immunogenicity against tisagenlecleucel. CD4 and CD8 T cell net responses (in %) were calculated for 2 non-overlapping CTL019 peptide pools (i.e., Pool 1 and Pool 2). (Lymphocyte subsets of B and T cells and description of associated safety events)

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=52 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=6 Participants
Pediatric participants with r/r B-cell ALL
Unknown
n=6 Participants
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 36: Pool 2 CD3+ CD8+ IFNg+
9.6 Percentage of participants
0 Percentage of participants
0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 6: Pool 2 CD3+ CD8+ IFNg+
67.3 Percentage of participants
16.7 Percentage of participants
16.7 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 12: Pool 2 CD3+ CD8+ IFNg+
48.1 Percentage of participants
0 Percentage of participants
0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 24: Pool 2 CD3+ CD4+ IFNg+
17.3 Percentage of participants
0 Percentage of participants
0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 36: Pool 2 CD3+ CD4+ IFNg+
9.6 Percentage of participants
0 Percentage of participants
0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Baseline: Pool 1 CD3+ CD8+ IFNg+
92.3 Percentage of participants
83.3 Percentage of participants
50.0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Day 14: Pool 1 CD3+ CD8+ IFNg+
82.7 Percentage of participants
100 Percentage of participants
50.0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Day 28: Pool 1 CD3+ CD8+ IFNg+
94.2 Percentage of participants
100 Percentage of participants
50.0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 3: Pool 1 CD3+ CD8+ IFNg+
82.7 Percentage of participants
16.7 Percentage of participants
33.3 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 6: Pool 1 CD3+ CD8+ IFNg+
67.3 Percentage of participants
16.7 Percentage of participants
16.7 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 12: Pool 1 CD3+ CD8+ IFNg+
48.1 Percentage of participants
0 Percentage of participants
0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 24: Pool 1 CD3+ CD8+ IFNg+
17.3 Percentage of participants
0 Percentage of participants
0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 36: Pool 1 CD3+ CD8+ IFNg+
9.6 Percentage of participants
0 Percentage of participants
0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Baseline: Pool 2 CD3+ CD8+ IFNg+
92.3 Percentage of participants
83.3 Percentage of participants
50.0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Day 14: Pool 2 CD3+ CD8+ IFNg+
82.7 Percentage of participants
100 Percentage of participants
50.0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Day 28: Pool 2 CD3+ CD8+ IFNg+
94.2 Percentage of participants
100 Percentage of participants
50.0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 3: Pool 2 CD3+ CD8+ IFNg+
82.7 Percentage of participants
16.7 Percentage of participants
33.3 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 24: Pool 2 CD3+ CD8+ IFNg+
17.3 Percentage of participants
0 Percentage of participants
0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Baseline: Pool 1 CD3+ CD4+ IFNg+
92.3 Percentage of participants
83.3 Percentage of participants
50.0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Day 14: Pool 1 CD3+ CD4+ IFNg+
82.7 Percentage of participants
100 Percentage of participants
50.0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Day 28: Pool 1 CD3+ CD4+ IFNg+
94.2 Percentage of participants
100 Percentage of participants
50.0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 3: Pool 1 CD3+ CD4+ IFNg+
82.7 Percentage of participants
16.7 Percentage of participants
33.3 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 6: Pool 1 CD3+ CD4+ IFNg+
67.3 Percentage of participants
16.7 Percentage of participants
57.8 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 12: Pool 1 CD3+ CD4+ IFNg+
48.1 Percentage of participants
0 Percentage of participants
0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 24: Pool 1 CD3+ CD4+ IFNg+
17.3 Percentage of participants
0 Percentage of participants
0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 36: Pool 1 CD3+ CD4+ IFNg+
9.6 Percentage of participants
0 Percentage of participants
0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Baseline: Pool 2 CD3+ CD4+ IFNg+
92.3 Percentage of participants
83.3 Percentage of participants
50.0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Day 14: Pool 2 CD3+ CD4+ IFNg+
82.7 Percentage of participants
100 Percentage of participants
50.0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Day 28: Pool 2 CD3+ CD4+ IFNg+ )
94.2 Percentage of participants
100 Percentage of participants
50.0 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 3: Pool 2 CD3+ CD4+ IFNg+
82.7 Percentage of participants
16.7 Percentage of participants
33.3 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 6: Pool 2 CD3+ CD4+ IFNg+
67.3 Percentage of participants
16.7 Percentage of participants
16.7 Percentage of participants
—
—
Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Month 12: Pool 2 CD3+ CD4+ IFNg+
48.1 Percentage of participants
0 Percentage of participants
0 Percentage of participants
—
—

SECONDARY outcome

Timeframe: 0 - 28 days post-infusion for AUC0-28d and 0 - 84 days post-infusion for AUC0-84d

Population: Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data.

Characterize the in vivo cellular pharmacokinetic (PK) profile. AUC0-28d and AUC0-84d is defined as the AUC from time zero to day 28 and 84 or other disease assessment days, in peripheral blood (% or copies/μg x days). Data was only reported for evaluable PK parameters. The Overall Number of Participants Analyzed represents all participants for which a baseline assessment was collected for this Outcome Measure, and therefore these participants did contribute data to this estimation parameter, whereas the Number Analyzed per Row represents the number of participants with data available at either 28 or 84 days.

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=52 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=6 Participants
Pediatric participants with r/r B-cell ALL
Unknown
n=6 Participants
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: AUC0-28d and AUC0-84d
AUC0-28d
261000 copies/µg*days
Geometric Coefficient of Variation 199.8
151000 copies/µg*days
Geometric Coefficient of Variation 71.7
617000 copies/µg*days
Geometric Coefficient of Variation NA
N/A = Too few participants to calculate geometric CV
—
—
Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: AUC0-28d and AUC0-84d
AUC0-84d
368000 copies/µg*days
Geometric Coefficient of Variation 182.9
443000 copies/µg*days
Geometric Coefficient of Variation 79.9
1340000 copies/µg*days
Geometric Coefficient of Variation NA
N/A = Too few participants to calculate geometric CV
—
—

SECONDARY outcome

Timeframe: Day 28

Population: Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data

Characterize the in vivo cellular pharmacokinetic (PK) profile. Cmax is defined as the maximum (peak) observed in peripheral blood drug concentration after single dose administration (% or copies/μg).

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=52 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=5 Participants
Pediatric participants with r/r B-cell ALL
Unknown
n=3 Participants
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: Cmax
28300 copies/µg
Geometric Coefficient of Variation 197.0
15100 copies/µg
Geometric Coefficient of Variation 49.4
52500 copies/µg
Geometric Coefficient of Variation 91.1
—
—

SECONDARY outcome

Timeframe: Day 28

Population: Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data

Characterize the in vivo cellular pharmacokinetic (PK) profile. Tmax is defined as the time to reach maximum (peak) peripheral blood drug concentration after single dose administration (days)

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=52 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=5 Participants
Pediatric participants with r/r B-cell ALL
Unknown
n=2 Participants
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: Tmax
9.84 days
Interval 6.74 to 54.8
20.0 days
Interval 13.9 to 22.8
11.9 days
Interval 11.0 to 12.9
—
—

SECONDARY outcome

Timeframe: Day 28

Population: Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data

Characterize the in vivo cellular pharmacokinetic (PK) profile. T1/2 is defined as the half-life associated with the disposition phase slopes (alpha, beta, gamma etc.) of a semi logarithmic concentration-time curve (days) in peripheral blood

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=34 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=2 Participants
Pediatric participants with r/r B-cell ALL
Unknown
n=1 Participants
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: T1/2
31.9 days
Geometric Coefficient of Variation 415.1
4.36 days
Geometric Coefficient of Variation 421.2
42.1 days
Geometric Coefficient of Variation NA
N/A = with only 1 subject, geometric CV could not be calculated
—
—

SECONDARY outcome

Timeframe: Day 28

Population: Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data

Characterize the in vivo cellular pharmacokinetic (PK) profile. Clast is defined as the last observed quantifiable concentration in peripheral blood (% or copies/ug)

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=52 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=5 Participants
Pediatric participants with r/r B-cell ALL
Unknown
n=1 Participants
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: Clast
223 copies/µg
Geometric Coefficient of Variation 283.4
1980 copies/µg
Geometric Coefficient of Variation 207.5
80.3 copies/µg
Geometric Coefficient of Variation NA
N/A = with only 1 subject, geometric CV could not be calculated
—
—

SECONDARY outcome

Timeframe: Day 28

Population: Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data

Characterize the in vivo cellular pharmacokinetic (PK) profile. Tlast is defined as the time of last observed quantifiable concentration in peripheral blood (days)"

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=52 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=5 Participants
Pediatric participants with r/r B-cell ALL
Unknown
n=1 Participants
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: Tlast
179 days
Interval 17.8 to 921.0
26.9 days
Interval 26.7 to 96.1
210 days
Interval 210.0 to 210.0
—
—

SECONDARY outcome

Timeframe: At time of relapse up to 60 months

Population: FAS patients who achieved CR \& CRi and then relapsed. FAS: All subjects who received an infusion of CTL019

The CD19 status of bone marrow/blood relapse was categorized as follows: CD19 positive, CD19 dim, CD19 negative, CD19 positive/negative \& CD19 unknown

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=21 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
CD19 Status of Bone Marrow/Blood Relapse in FAS Patients Who Achieved CR or CRi and Then Relapsed
CD19 status of BM/blood relapse:positive
22.2 Percentage of participants
—
—
—
—
CD19 Status of Bone Marrow/Blood Relapse in FAS Patients Who Achieved CR or CRi and Then Relapsed
CD19 status of BM/blood relapse: dim
5.6 Percentage of participants
—
—
—
—
CD19 Status of Bone Marrow/Blood Relapse in FAS Patients Who Achieved CR or CRi and Then Relapsed
CD19 status of BM/blood relapse: negative
16.7 Percentage of participants
—
—
—
—
CD19 Status of Bone Marrow/Blood Relapse in FAS Patients Who Achieved CR or CRi and Then Relapsed
CD19 status of BM/blood relapse: +ve/-ve
16.7 Percentage of participants
—
—
—
—
CD19 Status of Bone Marrow/Blood Relapse in FAS Patients Who Achieved CR or CRi and Then Relapsed
CD19 status of BM/blood relapse: Unknown
55.6 Percentage of participants
—
—
—
—

SECONDARY outcome

Timeframe: At time of relapse up to 60 months

Population: FAS patients who achieved CR \& CRi and then relapsed. FAS: All subjects who received an infusion of CTL019

This is the site of involvement of initial relapse after achieving a best overall response of CR/CRi.

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=21 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Site of Initial Relapse Among FAS Patients Who Achieved CR/CRi and Then Relapsed
BM/blood relapse
72.2 Percentage of participants
—
—
—
—
Site of Initial Relapse Among FAS Patients Who Achieved CR/CRi and Then Relapsed
Extramedullary only
27.8 Percentage of participants
—
—
—
—
Site of Initial Relapse Among FAS Patients Who Achieved CR/CRi and Then Relapsed
Unknown
16.7 Percentage of participants
—
—
—
—

SECONDARY outcome

Timeframe: during the whole study, up to 60 months

Population: FAS patients who achieved CR or CRi. FAS: All subjects who received an infusion of CTL019

Time to B cell recovery was defined as the time from onset of remission to the earliest time when the percentage of CD19+ total B cell among viable WBC is ≥ 1% or among lymphocyte is at least 3%.

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=54 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
Pediatric participants with r/r B-cell ALL
Unknown
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Time to B-cell Recovery in Participants Who Achieved CR or CRi by IRC
35.5 Months
Interval 7.6 to
N/A = not estimable because there were not enough participants who had events to estimate the upper limit of the median
—
—
—
—

SECONDARY outcome

Timeframe: Enrollment/Pre-Chemotherapy; Pre-infusion; Baseline; Day 7; Day 14; Day 21; Day 28; Month 3; Month 6; Month 9; Month 12; Month 24; Month 36

Population: Safety set: All subjects who received an infusion of tisagenlecleucel

The levels (%) of CD19+ total B cells amongst viable white blood cells (WBC) in peripheral blood

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=52 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=6 Participants
Pediatric participants with r/r B-cell ALL
Unknown
n=6 Participants
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
All participants with \& without CRS
Percentage of CD19+ B Cell Levels in Peripheral Blood by Day 28 Disease Response by IRC Assessment
Enrollment/Pre-Chemotherapy
26.8 Percentage of CD19+ B cell levels
Standard Deviation 28.733
52.29 Percentage of CD19+ B cell levels
Standard Deviation 36.758
32.66 Percentage of CD19+ B cell levels
Standard Deviation 28.102
—
—
Percentage of CD19+ B Cell Levels in Peripheral Blood by Day 28 Disease Response by IRC Assessment
Pre-infusion
0.02 Percentage of CD19+ B cell levels
Standard Deviation NA
N/A = Too few participants to calculate geometric SD
—
46.80 Percentage of CD19+ B cell levels
Standard Deviation NA
N/A = Too few participants to calculate geometric SD
—
—
Percentage of CD19+ B Cell Levels in Peripheral Blood by Day 28 Disease Response by IRC Assessment
Baseline
25.11 Percentage of CD19+ B cell levels
Standard Deviation 28.584
52.29 Percentage of CD19+ B cell levels
Standard Deviation 36.758
29.50 Percentage of CD19+ B cell levels
Standard Deviation 24.466
—
—
Percentage of CD19+ B Cell Levels in Peripheral Blood by Day 28 Disease Response by IRC Assessment
Day 7
1.06 Percentage of CD19+ B cell levels
Standard Deviation 3.735
34.40 Percentage of CD19+ B cell levels
Standard Deviation 46.922
23.18 Percentage of CD19+ B cell levels
Standard Deviation 38.772
—
—
Percentage of CD19+ B Cell Levels in Peripheral Blood by Day 28 Disease Response by IRC Assessment
Day 14
0.73 Percentage of CD19+ B cell levels
Standard Deviation 5.096
33.76 Percentage of CD19+ B cell levels
Standard Deviation 45.359
3.43 Percentage of CD19+ B cell levels
Standard Deviation 7.520
—
—
Percentage of CD19+ B Cell Levels in Peripheral Blood by Day 28 Disease Response by IRC Assessment
Day 21
0.01 Percentage of CD19+ B cell levels
Standard Deviation 0.017
19.67 Percentage of CD19+ B cell levels
Standard Deviation 32.553
16.13 Percentage of CD19+ B cell levels
Standard Deviation 35.929
—
—
Percentage of CD19+ B Cell Levels in Peripheral Blood by Day 28 Disease Response by IRC Assessment
Day 28
0.02 Percentage of CD19+ B cell levels
Standard Deviation 0.069
34.97 Percentage of CD19+ B cell levels
Standard Deviation 36.648
0.02 Percentage of CD19+ B cell levels
Standard Deviation 0.012
—
—
Percentage of CD19+ B Cell Levels in Peripheral Blood by Day 28 Disease Response by IRC Assessment
Month 3
0.79 Percentage of CD19+ B cell levels
Standard Deviation 1.971
0.57 Percentage of CD19+ B cell levels
Standard Deviation NA
N/A = Too few participants to calculate geometric SD
11.26 Percentage of CD19+ B cell levels
Standard Deviation 15.917
—
—
Percentage of CD19+ B Cell Levels in Peripheral Blood by Day 28 Disease Response by IRC Assessment
Month 6
1.86 Percentage of CD19+ B cell levels
Standard Deviation 7.958
9.70 Percentage of CD19+ B cell levels
Standard Deviation NA
N/A = Too few participants to calculate geometric SD
0.01 Percentage of CD19+ B cell levels
Standard Deviation NA
N/A = Too few participants to calculate geometric SD
—
—
Percentage of CD19+ B Cell Levels in Peripheral Blood by Day 28 Disease Response by IRC Assessment
Month 9
0.63 Percentage of CD19+ B cell levels
Standard Deviation 2.180
—
—
—
—
Percentage of CD19+ B Cell Levels in Peripheral Blood by Day 28 Disease Response by IRC Assessment
Month 12
0.85 Percentage of CD19+ B cell levels
Standard Deviation 2.420
—
—
—
—
Percentage of CD19+ B Cell Levels in Peripheral Blood by Day 28 Disease Response by IRC Assessment
Month 24
1.74 Percentage of CD19+ B cell levels
Standard Deviation 3.446
—
—
—
—
Percentage of CD19+ B Cell Levels in Peripheral Blood by Day 28 Disease Response by IRC Assessment
Month 36
1.10 Percentage of CD19+ B cell levels
Standard Deviation 2.106
—
—
—
—

SECONDARY outcome

Timeframe: Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3

Population: Safety set: All subjects who received an infusion of tisagenlecleucel

C-Reactive Protein at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=14 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=31 Participants
Pediatric participants with r/r B-cell ALL
Unknown
n=8 Participants
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
n=11 Participants
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
n=64 Participants
All participants with \& without CRS
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: C Reactive Protein (CRP)
Pre-infusion
9.21 mg/L
Interval 2.9 to 34.0
8.27 mg/L
Interval 2.0 to 1530.0
7.45 mg/L
Interval 0.6 to 50.0
9.00 mg/L
Interval 2.0 to 153.0
9.00 mg/L
Interval 0.6 to 1530.0
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: C Reactive Protein (CRP)
Baseline (BL)
9.21 mg/L
Interval 2.9 to 34.0
9.04 mg/L
Interval 2.0 to 1530.0
7.45 mg/L
Interval 0.6 to 50.0
9.00 mg/L
Interval 2.0 to 153.0
9.00 mg/L
Interval 0.6 to 1530.0
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: C Reactive Protein (CRP)
Change from BL Day7
0.00 mg/L
Interval -15.0 to 25.0
15.00 mg/L
Interval -460.0 to 215.0
79.55 mg/L
Interval -2.0 to 380.0
108.00 mg/L
Interval -125.0 to 255.0
9.10 mg/L
Interval -460.0 to 380.0
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: C Reactive Protein (CRP)
Change from BL Day 14
0.00 mg/L
Interval -20.0 to 24.0
0.00 mg/L
Interval -1031.0 to 215.0
10.50 mg/L
Interval -42.0 to 199.0
15.70 mg/L
Interval -148.0 to 100.0
0.00 mg/L
Interval -1031.0 to 215.0
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: C Reactive Protein (CRP)
Change from BL Day 21
0.00 mg/L
Interval -14.0 to 29.5
-0.80 mg/L
Interval -1460.0 to 677.0
2.00 mg/L
Interval -42.0 to 37.0
-3.00 mg/L
Interval -57.0 to 73.0
0.00 mg/L
Interval -1460.0 to 677.0
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: C Reactive Protein (CRP)
Change from BL Day 28
0.00 mg/L
Interval -15.0 to 47.0
-0.70 mg/L
Interval -1487.0 to 47.0
1.50 mg/L
Interval -45.0 to 55.0
-3.00 mg/L
Interval -151.0 to 27.0
0.00 mg/L
Interval -1487.0 to 55.0
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: C Reactive Protein (CRP)
Change from BL Month 3
0.00 mg/L
Interval -12.1 to 101.0
-1.00 mg/L
Interval -1501.0 to 7.1
0.00 mg/L
Interval -3.0 to 120.5
-1.00 mg/L
Interval -149.0 to 13.0
-0.65 mg/L
Interval -1501.0 to 120.5

SECONDARY outcome

Timeframe: Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3

Population: Safety set: All subjects who received an infusion of tisagenlecleucel

Ferritin at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=14 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=31 Participants
Pediatric participants with r/r B-cell ALL
Unknown
n=8 Participants
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
n=11 Participants
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
n=64 Participants
All participants with \& without CRS
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Ferritin
Pre-infusion
1865.20 ug/L
Interval 459.0 to 5015.0
2202.22 ug/L
Interval 230.0 to 18061.0
1906.95 ug/L
Interval 357.0 to 4200.0
2078.40 ug/L
Interval 487.0 to 13553.9
1983.90 ug/L
Interval 230.0 to 18061.0
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Ferritin
Baseline (BL)
1865.20 ug/L
Interval 459.0 to 5015.0
2202.22 ug/L
Interval 230.0 to 18061.0
1906.95 ug/L
Interval 357.0 to 4200.0
2078.40 ug/L
Interval 487.0 to 13553.9
1983.90 ug/L
Interval 230.0 to 18061.0
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Ferritin
Change from BL Day7
-146.50 ug/L
Interval -721.4 to 710.0
377.80 ug/L
Interval -1468.0 to 522220.0
22735.10 ug/L
Interval -330.0 to 182380.0
23788.71 ug/L
Interval -161.0 to 269529.0
358.90 ug/L
Interval -1468.0 to 269529.0
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Ferritin
Change from BL Day 14
-321.30 ug/L
Interval -2035.1 to 520.0
861.50 ug/L
Interval -3483.3 to 59435.9
10728.40 ug/L
Interval 1262.0 to 104170.0
18580.01 ug/L
Interval 707.0 to 110421.6
973.00 ug/L
Interval -3483.3 to 110421.6
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Ferritin
Change from BL Day 21
58.00 ug/L
Interval -2302.0 to 524.0
331.00 ug/L
Interval -3571.6 to 43336.0
3299.85 ug/L
Interval -600.0 to 121100.0
3199.00 ug/L
Interval -17.0 to 12957.4
490.00 ug/L
Interval -3571.6 to 121100.0
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Ferritin
Change from BL Day 28
121.10 ug/L
Interval -2952.0 to 1510.0
283.00 ug/L
Interval to 9879.0
1104.00 ug/L
Interval -890.0 to 331000.0
1211.00 ug/L
Interval -606.0 to 12957.4
280.50 ug/L
Interval -6443.7 to 33100.0
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Ferritin
Change from BL Month 3
-124.90 ug/L
Interval -2418.0 to 1985.5
-358.00 ug/L
Interval -5415.0 to 7050.0
-487.60 ug/L
Interval -1500.0 to 8140.0
-377.00 ug/L
Interval -1808.2 to 2641.6
-330.00 ug/L
Interval -5415.0 to 8140.0

SECONDARY outcome

Timeframe: Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3

Population: Safety set: All subjects who received an infusion of tisagenlecleucel

INF-gamma at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=14 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=31 Participants
Pediatric participants with r/r B-cell ALL
Unknown
n=8 Participants
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
n=11 Participants
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
n=64 Participants
All participants with \& without CRS
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: INF-gamma
Pre-infusion
29.63 pg/mL
Interval 1.0 to 283.0
23.39 pg/mL
Interval 1.0 to 242.8
15.73 pg/mL
Interval 6.4 to 31.5
5.79 pg/mL
Interval 2.5 to 34.1
20.22 pg/mL
Interval 1.0 to 283.0
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: INF-gamma
Baseline (BL)
29.63 pg/mL
Interval 1.0 to 283.0
22.51 pg/mL
Interval 1.0 to 242.8
15.73 pg/mL
Interval 6.4 to 31.5
4.77 pg/mL
Interval 1.0 to 34.1
15.75 pg/mL
Interval 1.0 to 283.0
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: INF-gamma
Change from BL Day7
0.47 pg/mL
Interval -167.9 to 140.6
52.59 pg/mL
Interval -201.2 to 39452.4
3023.82 pg/mL
Interval -14.7 to 162376.0
1347.48 pg/mL
Interval 60.2 to 89599.0
72.09 pg/mL
Interval -201.2 to 162376.0
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: INF-gamma
Change from BL Day 14
-5.10 pg/mL
Interval -278.3 to 39.2
-4.44 pg/mL
Interval -194.8 to 131.1
58.65 pg/mL
Interval -14.3 to 1328.7
102.04 pg/mL
Interval -2.2 to 8925.9
1.32 pg/mL
Interval -278.3 to 8925.9
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: INF-gamma
Change from BL Day 21
-4.97 pg/mL
Interval -264.0 to 58.5
1.06 pg/mL
Interval -219.7 to 1384.6
0.53 pg/mL
Interval -22.8 to 1048.7
5.23 pg/mL
Interval -4.0 to 167.1
-0.89 pg/mL
Interval -264.0 to 1384.6
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: INF-gamma
Change from BL Day 28
-6.93 pg/mL
Interval -269.9 to 60.4
0.20 pg/mL
Interval -223.6 to 738.8
-1.19 pg/mL
Interval -26.1 to 187.7
0.36 pg/mL
Interval -4.7 to 138.4
-0.62 pg/mL
Interval -269.9 to 738.8
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: INF-gamma
Change from BL Month 3
-6.08 pg/mL
Interval -278.6 to 167.5
-14.58 pg/mL
Interval -173.9 to 7.6
21.25 pg/mL
Interval -7.7 to 37.2
-0.67 pg/mL
Interval -4.4 to 23.1
-5.71 pg/mL
Interval -278.6 to 167.5

SECONDARY outcome

Timeframe: Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3

Population: Safety set: All subjects who received an infusion of tisagenlecleucel

IL-6 at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=14 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=31 Participants
Pediatric participants with r/r B-cell ALL
Unknown
n=8 Participants
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
n=11 Participants
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
n=64 Participants
All participants with \& without CRS
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-6 (IL-6)
Pre-infusion
2.42 pg/mL
Interval 0.4 to 12.0
2.89 pg/mL
Interval 0.2 to 19.6
1.00 pg/mL
Interval 0.8 to 9.4
2.27 pg/mL
Interval 0.4 to 6.2
2.27 pg/mL
Interval 0.2 to 19.6
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-6 (IL-6)
Baseline (BL)
2.42 pg/mL
Interval 0.4 to 12.0
2.83 pg/mL
Interval 0.2 to 19.6
1.00 pg/mL
Interval 0.8 to 9.4
1.84 pg/mL
Interval 0.2 to 6.2
1.99 pg/mL
Interval 0.2 to 19.6
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-6 (IL-6)
Change from BL Day7
-0.23 pg/mL
Interval -9.6 to 4.3
2.64 pg/mL
Interval -13.1 to 61.3
52.75 pg/mL
Interval -0.6 to 7201.6
141.68 pg/mL
Interval 1.3 to 12615.8
2.64 pg/mL
Interval -13.1 to 12615.8
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-6 (IL-6)
Change from BL Day 14
-0.36 pg/mL
Interval -2.3 to 4.1
-0.67 pg/mL
Interval -13.4 to 21.5
8.88 pg/mL
Interval -0.6 to 30.4
165.16 pg/mL
Interval -0.2 to 5734.8
-0.11 pg/mL
Interval -13.4 to 5734.8
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-6 (IL-6)
Change from BL Day 21
-0.97 pg/mL
Interval -5.3 to 5.3
-0.46 pg/mL
Interval -15.4 to 103.4
1.65 pg/mL
Interval -0.6 to 265.2
50.75 pg/mL
Interval -0.2 to 5734.8
-0.09 pg/mL
Interval -15.4 to 5734.8
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-6 (IL-6)
Change from BL Day 28
-0.98 pg/mL
Interval -7.8 to 1.9
-0.28 pg/mL
Interval -17.5 to 33.0
0.91 pg/mL
Interval -0.6 to 138.6
38.13 pg/mL
Interval 0.0 to 2148.4
-0.03 pg/mL
Interval -17.5 to 2148.4
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-6 (IL-6)
Change from BL Month 3
0.34 pg/mL
Interval -10.8 to 22.7
-0.59 pg/mL
Interval -8.9 to 1.2
0.56 pg/mL
Interval -0.6 to 30.3
0.40 pg/mL
Interval -0.9 to 3.2
-0.19 pg/mL
Interval -10.8 to 30.3

SECONDARY outcome

Timeframe: Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3

Population: Safety set: All subjects who received an infusion of tisagenlecleucel

IL-2 at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3

Outcome measures

Outcome measures
Measure
Tisagenlecleucel (CTL019) - All Participants
n=14 Participants
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Tisagenlecleucel (CTL019) - IRC Assessment
n=31 Participants
Pediatric participants with r/r B-cell ALL
Unknown
n=8 Participants
unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
Grade 4
n=11 Participants
Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
All Participants
n=64 Participants
All participants with \& without CRS
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-2 (IL-2)
Pre-infusion
2.3 pg/mL
Interval 2.3 to 2.3
2.3 pg/mL
Interval 2.3 to 2.3
2.3 pg/mL
Interval 2.3 to 2.3
2.3 pg/mL
Interval 2.3 to 2.3
2.3 pg/mL
Interval 2.3 to 2.3
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-2 (IL-2)
Baseline (BL)
2.3 pg/mL
Interval 2.3 to 2.3
2.3 pg/mL
Interval 2.3 to 2.3
2.3 pg/mL
Interval 2.3 to 2.3
2.3 pg/mL
Interval 2.3 to 2.3
2.3 pg/mL
Interval 2.3 to 2.3
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-2 (IL-2)
Change from BL Day7
3.33 pg/mL
Interval 0.0 to 6.7
3.15 pg/mL
Interval 0.0 to 7.0
13.14 pg/mL
Interval 5.0 to 63.7
7.48 pg/mL
Interval 2.9 to 12.1
5.16 pg/mL
Interval 0.0 to 63.7
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-2 (IL-2)
Change from BL Day 14
NA pg/mL
N/A = below limit of detection
0.00 pg/mL
Interval 0.0 to 0.0
NA pg/mL
N/A = below limit of detection
4.56 pg/mL
Interval 4.56 to 4.6
0.00 pg/mL
Interval 0.0 to 4.6
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-2 (IL-2)
Change from BL Day 21
NA pg/mL
N/A = below limit of detection
NA pg/mL
N/A = below limit of detection
NA pg/mL
N/A = below limit of detection
NA pg/mL
N/A = below limit of detection
NA pg/mL
N/A = below limit of detection
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-2 (IL-2)
Change from BL Day 28
NA pg/mL
N/A = below limit of detection
NA pg/mL
N/A = below limit of detection
NA pg/mL
N/A = below limit of detection
NA pg/mL
N/A = below limit of detection
NA pg/mL
N/A = below limit of detection
Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-2 (IL-2)
Change from BL Month 3
NA pg/mL
N/A = below limit of detection
NA pg/mL
N/A = below limit of detection
NA pg/mL
N/A = below limit of detection
NA pg/mL
N/A = below limit of detection
NA pg/mL
N/A = below limit of detection

Adverse Events

Tisagenlecleucel (CTL019) - All Participants

Serious events: 52 serious events
Other events: 64 other events
Deaths: 30 deaths

Serious adverse events

Serious adverse events
Measure
Tisagenlecleucel (CTL019) - All Participants
n=64 participants at risk
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Immune system disorders
Graft versus host disease in gastrointestinal tract
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Blood and lymphatic system disorders
Disseminated intravascular coagulation
3.1%
2/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Blood and lymphatic system disorders
Eosinophilia
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Blood and lymphatic system disorders
Febrile neutropenia
35.9%
23/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Blood and lymphatic system disorders
Neutropenia
4.7%
3/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Cardiac disorders
Atrioventricular block second degree
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Cardiac disorders
Ventricular tachycardia
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Eye disorders
Papilloedema
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Eye disorders
Vision blurred
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Gastrointestinal disorders
Diarrhoea
3.1%
2/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Gastrointestinal disorders
Enterocolitis
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Gastrointestinal disorders
Intestinal obstruction
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Gastrointestinal disorders
Pancreatitis
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Gastrointestinal disorders
Stomatitis
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Gastrointestinal disorders
Vomiting
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
General disorders
Malaise
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
General disorders
Physical deconditioning
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
General disorders
Pyrexia
10.9%
7/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Immune system disorders
Cytokine release syndrome
64.1%
41/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Bacterial sepsis
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Campylobacter infection
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Catheter site infection
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Cellulitis of male external genital organ
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Cholecystitis infective
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Clostridium difficile colitis
3.1%
2/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Clostridium difficile infection
4.7%
3/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Corona virus infection
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Enterovirus infection
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Gastroenteritis
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Gastroenteritis norovirus
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Herpes zoster
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Parainfluenzae virus infection
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Pneumonia
3.1%
2/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Respiratory syncytial virus infection
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Respiratory tract infection
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Respiratory tract infection viral
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Rhinovirus infection
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Rotavirus infection
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Sepsis
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Septic embolus
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Staphylococcal infection
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Upper respiratory tract infection
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Urinary tract infection
3.1%
2/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Vascular device infection
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Viral upper respiratory tract infection
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Vulvovaginal candidiasis
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Injury, poisoning and procedural complications
Procedural pain
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Injury, poisoning and procedural complications
Transfusion related complication
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Investigations
Alanine aminotransferase increased
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Investigations
White blood cell count decreased
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Metabolism and nutrition disorders
Acidosis
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Metabolism and nutrition disorders
Decreased appetite
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Metabolism and nutrition disorders
Dehydration
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Metabolism and nutrition disorders
Tumour lysis syndrome
3.1%
2/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Musculoskeletal and connective tissue disorders
Flank pain
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Musculoskeletal and connective tissue disorders
Osteonecrosis
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Musculoskeletal and connective tissue disorders
Pain in extremity
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Nervous system disorders
Embolic stroke
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Nervous system disorders
Encephalopathy
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Nervous system disorders
Headache
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Nervous system disorders
Idiopathic intracranial hypertension
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Nervous system disorders
Seizure
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Psychiatric disorders
Delirium
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Renal and urinary disorders
Acute kidney injury
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Renal and urinary disorders
Renal failure
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Reproductive system and breast disorders
Vaginal haemorrhage
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Respiratory, thoracic and mediastinal disorders
Hypoxia
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Respiratory, thoracic and mediastinal disorders
Pleural effusion
3.1%
2/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
3.1%
2/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Respiratory, thoracic and mediastinal disorders
Respiratory failure
4.7%
3/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Skin and subcutaneous tissue disorders
Ecchymosis
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Vascular disorders
Embolism
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Vascular disorders
Hypotension
10.9%
7/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).

Other adverse events

Other adverse events
Measure
Tisagenlecleucel (CTL019) - All Participants
n=64 participants at risk
Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
Blood and lymphatic system disorders
Anaemia
42.2%
27/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Blood and lymphatic system disorders
Lymphopenia
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Blood and lymphatic system disorders
Neutropenia
12.5%
8/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Blood and lymphatic system disorders
Thrombocytopenia
15.6%
10/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Cardiac disorders
Sinus tachycardia
9.4%
6/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Cardiac disorders
Tachycardia
23.4%
15/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Eye disorders
Periorbital oedema
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Gastrointestinal disorders
Abdominal pain
17.2%
11/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Gastrointestinal disorders
Constipation
10.9%
7/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Gastrointestinal disorders
Diarrhoea
34.4%
22/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Gastrointestinal disorders
Nausea
39.1%
25/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Gastrointestinal disorders
Vomiting
42.2%
27/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
General disorders
Catheter site pain
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
General disorders
Chills
15.6%
10/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
General disorders
Fatigue
23.4%
15/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
General disorders
Pain
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
General disorders
Pyrexia
32.8%
21/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Immune system disorders
Cytokine release syndrome
29.7%
19/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Immune system disorders
Hypogammaglobulinaemia
51.6%
33/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Gastroenteritis
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Influenza
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Otitis media
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Rhinovirus infection
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Sinusitis
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Upper respiratory tract infection
12.5%
8/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Infections and infestations
Urinary tract infection
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Injury, poisoning and procedural complications
Infusion related reaction
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Injury, poisoning and procedural complications
Procedural pain
7.8%
5/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Investigations
Activated partial thromboplastin time prolonged
7.8%
5/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Investigations
Alanine aminotransferase increased
32.8%
21/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Investigations
Aspartate aminotransferase increased
31.2%
20/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Investigations
Blood bilirubin increased
12.5%
8/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Investigations
Blood creatinine increased
14.1%
9/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Investigations
Blood fibrinogen decreased
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Investigations
Blood immunoglobulin M decreased
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Investigations
International normalised ratio increased
14.1%
9/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Investigations
Lymphocyte count decreased
25.0%
16/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Investigations
Neutrophil count decreased
43.8%
28/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Investigations
Platelet count decreased
31.2%
20/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Investigations
Prothrombin time prolonged
14.1%
9/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Investigations
Weight decreased
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Investigations
White blood cell count decreased
54.7%
35/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Metabolism and nutrition disorders
Decreased appetite
32.8%
21/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Metabolism and nutrition disorders
Hypernatraemia
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Metabolism and nutrition disorders
Hyperphosphataemia
12.5%
8/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Metabolism and nutrition disorders
Hypoalbuminaemia
7.8%
5/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Metabolism and nutrition disorders
Hypokalaemia
29.7%
19/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Metabolism and nutrition disorders
Hypophosphataemia
15.6%
10/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Musculoskeletal and connective tissue disorders
Arthralgia
7.8%
5/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Musculoskeletal and connective tissue disorders
Myalgia
7.8%
5/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Musculoskeletal and connective tissue disorders
Pain in extremity
15.6%
10/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Nervous system disorders
Dizziness
9.4%
6/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Nervous system disorders
Headache
37.5%
24/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Psychiatric disorders
Anxiety
10.9%
7/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Psychiatric disorders
Confusional state
9.4%
6/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Renal and urinary disorders
Acute kidney injury
7.8%
5/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Renal and urinary disorders
Haematuria
7.8%
5/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Respiratory, thoracic and mediastinal disorders
Cough
21.9%
14/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Respiratory, thoracic and mediastinal disorders
Epistaxis
15.6%
10/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Respiratory, thoracic and mediastinal disorders
Hypoxia
9.4%
6/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Respiratory, thoracic and mediastinal disorders
Nasal congestion
7.8%
5/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
9.4%
6/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Respiratory, thoracic and mediastinal disorders
Pleural effusion
9.4%
6/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
7.8%
5/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
9.4%
6/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Respiratory, thoracic and mediastinal disorders
Tachypnoea
7.8%
5/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Skin and subcutaneous tissue disorders
Dry skin
7.8%
5/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Skin and subcutaneous tissue disorders
Erythema
7.8%
5/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Skin and subcutaneous tissue disorders
Hyperhidrosis
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Skin and subcutaneous tissue disorders
Petechiae
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Skin and subcutaneous tissue disorders
Pruritus
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Skin and subcutaneous tissue disorders
Rash
12.5%
8/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Skin and subcutaneous tissue disorders
Rash maculo-papular
7.8%
5/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Vascular disorders
Hypertension
18.8%
12/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
Vascular disorders
Hypotension
14.1%
9/64 • Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.
AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

  • Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
  • Publication restrictions are in place

Restriction type: OTHER