Trial Outcomes & Findings for Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCR and 4-1BB Signaling Domains in Patients With Chemotherapy Resistant or Refractory Acute Lymphoblastic Leukemia (NCT NCT02030847)
NCT ID: NCT02030847
Last Updated: 2023-06-22
Results Overview
Overall Complete Remission Rate (ORR) which includes complete remission (CR) and CR with incomplete blood count recovery (CRi) at Day 28. Overall Complete Remission Rate = CR+ CRi
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
28 Days
Results posted on
2023-06-22
Participant Flow
Patients were identified through the clinical practices of the investigator or sub-investigators and through referrals from outside hospitals and physicians. No direct-to-patient advertising was performed.
Participant milestones
| Measure |
Arm1
Phase II study to determine the efficacy \& safety of a single infusion of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as "CART-19" cells) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
CART-19: CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR:41BB administered by a single i.v. infusion of 1 to 5 x 10\^8 transduced CAR T cells
CART-19: As of June 2014, dose was reduced to a single dose of 1-5x10\^7 CART-19 cells.
CART-19: In the protocol amendment in November 2014, the dose remained 1-5 x 10\^7 CART-19 cells, but was revised to be administered via split dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3.
CART-19: In the protocol amendment in May 2015, the dose was changed to 1-5 x 10\^8 CART-19 cells administered via split dosing: 10% on Day 1 (1-5x10\^7), 30% on Day 2 (3x10\^7-1.5x10\^8), 60% on Day 3 (6x10\^7-3x10\^8
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
Arm1
Phase II study to determine the efficacy \& safety of a single infusion of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as "CART-19" cells) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
CART-19: CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR:41BB administered by a single i.v. infusion of 1 to 5 x 10\^8 transduced CAR T cells
CART-19: As of June 2014, dose was reduced to a single dose of 1-5x10\^7 CART-19 cells.
CART-19: In the protocol amendment in November 2014, the dose remained 1-5 x 10\^7 CART-19 cells, but was revised to be administered via split dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3.
CART-19: In the protocol amendment in May 2015, the dose was changed to 1-5 x 10\^8 CART-19 cells administered via split dosing: 10% on Day 1 (1-5x10\^7), 30% on Day 2 (3x10\^7-1.5x10\^8), 60% on Day 3 (6x10\^7-3x10\^8
|
|---|---|
|
Overall Study
Death
|
10
|
|
Overall Study
Disease Progression
|
15
|
|
Overall Study
New Cancer Therapy
|
8
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCR and 4-1BB Signaling Domains in Patients With Chemotherapy Resistant or Refractory Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Arm1
n=30 Participants
phase II study to determine the efficacy \& safety of a single infusion of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as "CART-19" cells) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
CART-19: CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR:41BB administered by a single i.v. infusion of 1 to 5 x 10\^8 transduced CAR T cells
CART-19: As of June 2014, dose was reduced to a single dose of 1-5x10\^7 CART-19 cells.
CART-19: In the protocol amendment in November 2014, the dose remained 1-5 x 10\^7 CART-19 cells, but was revised to be administered via split dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3.
CART-19: In the protocol amendment in May 2015, the dose was changed to 1-5 x 10\^8 CART-19 cells administered via split dosing: 10% on Day 1 (1-5x10\^7), 30% on Day 2 (3x10\^7-1.5x10\^8), 60% on Day 3 (6x10\^7-3x10\^8
|
|---|---|
|
Age, Continuous
|
39.6 years
STANDARD_DEVIATION 16.34 • n=5 Participants
|
|
Age, Customized
>=18 to <40 Years
|
18 participants
n=5 Participants
|
|
Age, Customized
>=40 to <65 Years
|
10 participants
n=5 Participants
|
|
Age, Customized
>=65 Years
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
28 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: Out of 42 enrolled, only 30 patients were infused with CART-19 product. 30 infused patients were considered for outcome measure.
Overall Complete Remission Rate (ORR) which includes complete remission (CR) and CR with incomplete blood count recovery (CRi) at Day 28. Overall Complete Remission Rate = CR+ CRi
Outcome measures
| Measure |
Arm1
n=30 Participants
phase II study to determine the efficacy \& safety of a single infusion of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as "CART-19" cells) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
CART-19: CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR:41BB administered by a single i.v. infusion of 1 to 5 x 10\^8 transduced CAR T cells
CART-19: As of June 2014, dose was reduced to a single dose of 1-5x10\^7 CART-19 cells.
CART-19: In the protocol amendment in November 2014, the dose remained 1-5 x 10\^7 CART-19 cells, but was revised to be administered via split dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3.
CART-19: In the protocol amendment in May 2015, the dose was changed to 1-5 x 10\^8 CART-19 cells administered via split dosing: 10% on Day 1 (1-5x10\^7), 30% on Day 2 (3x10\^7-1.5x10\^8), 60% on Day 3 (6x10\^7-3x10\^8
|
|---|---|
|
Overall Complete Remission Rate at Day 28 After CART-19 Therapy
Complete Remission (CR)
|
8 Participants
|
|
Overall Complete Remission Rate at Day 28 After CART-19 Therapy
CR with incomplete blood count recovery (CRi)
|
10 Participants
|
|
Overall Complete Remission Rate at Day 28 After CART-19 Therapy
No Response
|
6 Participants
|
|
Overall Complete Remission Rate at Day 28 After CART-19 Therapy
Unknown
|
6 Participants
|
SECONDARY outcome
Timeframe: from the start of the treatment until death, last follow up, relapse or start of new anticancer therapy, whichever comes first, assessed up to 12 monthsPopulation: Out of 42 enrolled, only 30 patients were infused with CART-19 product. 30 infused patients were considered for outcome measure.
For the secondary efficacy objectives for this study, the number of patients were computed with a best overall disease response of CR or CRi, where the best overall disease response is defined as the best disease response recorded from the start of the treatment until death, last follow up, relapse or start of new anticancer therapy, whichever comes first.
Outcome measures
| Measure |
Arm1
n=30 Participants
phase II study to determine the efficacy \& safety of a single infusion of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as "CART-19" cells) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
CART-19: CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR:41BB administered by a single i.v. infusion of 1 to 5 x 10\^8 transduced CAR T cells
CART-19: As of June 2014, dose was reduced to a single dose of 1-5x10\^7 CART-19 cells.
CART-19: In the protocol amendment in November 2014, the dose remained 1-5 x 10\^7 CART-19 cells, but was revised to be administered via split dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3.
CART-19: In the protocol amendment in May 2015, the dose was changed to 1-5 x 10\^8 CART-19 cells administered via split dosing: 10% on Day 1 (1-5x10\^7), 30% on Day 2 (3x10\^7-1.5x10\^8), 60% on Day 3 (6x10\^7-3x10\^8
|
|---|---|
|
Best Overall Response
Complete Remission (CR)
|
10 Participants
|
|
Best Overall Response
CR with incomplete blood count recovery (CRi)
|
1 Participants
|
|
Best Overall Response
No Response
|
8 Participants
|
|
Best Overall Response
Unknown
|
11 Participants
|
Adverse Events
Arm1
Serious events: 30 serious events
Other events: 30 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Arm1
n=30 participants at risk
Phase II study to determine the efficacy \& safety of a single infusion of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ \& 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as "CART-19" cells) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
CART-19: CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR:41BB administered by a single i.v. infusion of 1 to 5 x 10\^8 transduced CAR T cells.
CART-19: As of June 2014, dose was reduced to a single dose of 1-5x10\^7 CART-19 cells.
CART-19: In the protocol amendment in November 2014, the dose remained 1-5 x 10\^7 CART-19 cells, but was revised to be administered via split dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3.
CART-19: In the protocol amendment in May 2015, the dose was changed to 1-5 x 10\^8 CART-19 cells administered via split dosing: 10% on Day 1 (1-5x10\^7), 30% on Day 2 (3x10\^7-1.5x10\^8), 60% on Day 3 (6x10\^7-3x10\^8).
|
|---|---|
|
Immune system disorders
Cytokine Release Syndrome
|
70.0%
21/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Infections and infestations
Sepsis
|
10.0%
3/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Infections and infestations
Pneumonia
|
6.7%
2/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Metabolism and nutrition disorders
Acidosis
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Infections and infestations
Clostridium difficile infection
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Nervous system disorders
Haemorrhage intracranial
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Infections and infestations
Influenza
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Infections and infestations
Meningitis
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Nervous system disorders
Seizure
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Infections and infestations
Staphylococcal infection
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Psychiatric disorders
Suicide attempt
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Eye disorders
Vision blurred
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
Other adverse events
| Measure |
Arm1
n=30 participants at risk
Phase II study to determine the efficacy \& safety of a single infusion of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ \& 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as "CART-19" cells) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
CART-19: CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR:41BB administered by a single i.v. infusion of 1 to 5 x 10\^8 transduced CAR T cells.
CART-19: As of June 2014, dose was reduced to a single dose of 1-5x10\^7 CART-19 cells.
CART-19: In the protocol amendment in November 2014, the dose remained 1-5 x 10\^7 CART-19 cells, but was revised to be administered via split dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3.
CART-19: In the protocol amendment in May 2015, the dose was changed to 1-5 x 10\^8 CART-19 cells administered via split dosing: 10% on Day 1 (1-5x10\^7), 30% on Day 2 (3x10\^7-1.5x10\^8), 60% on Day 3 (6x10\^7-3x10\^8).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
53.3%
16/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.3%
4/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.7%
2/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
2/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Cardiac disorders
Pulseless electrical activity
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Cardiac disorders
Sinus Tachycarida
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Cardiac disorders
Tachycardia
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Ear and labyrinth disorders
Ear Pain
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Eye disorders
Eye haemorrhage
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Eye disorders
Papilloedema
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Eye disorders
Vision blurred
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Eye disorders
Vitreous haemorrhage
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
4/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Gastrointestinal disorders
Constipation
|
6.7%
2/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Gastrointestinal disorders
Stomatitis
|
6.7%
2/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
2/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Gastrointestinal disorders
Pancreatitis
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Gastrointestinal disorders
Tomgue ulceration
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
General disorders
Fatigue
|
16.7%
5/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
General disorders
Oedema peripheral
|
16.7%
5/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
General disorders
Chills
|
13.3%
4/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
General disorders
Pyrexia
|
13.3%
4/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
General disorders
Generalised Oedema
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
General disorders
Influenza like illness
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
General disorders
Medical device site pain
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Immune system disorders
Cytokine release syndrome
|
93.3%
28/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Infections and infestations
Sepsis
|
10.0%
3/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Infections and infestations
Clostridium difficile colitis
|
6.7%
2/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Infections and infestations
Pneumonia
|
6.7%
2/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Infections and infestations
Bacterial infection
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Infections and infestations
Clostridium difficile infection
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Infections and infestations
Enterocolitis infections
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Infections and infestations
Influenza
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Infections and infestations
Meningitis
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Infections and infestations
Oral candidiasis
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Infections and infestations
Staphylococoal infection
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Infections and infestations
Vira upper respiratory tract infection
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Injury, poisoning and procedural complications
Tendon injury
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Injury, poisoning and procedural complications
Thermal burn
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Investigations
Alanine aminotransferase increased
|
56.7%
17/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Investigations
Asprtate aminotransferase increased
|
56.7%
17/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Investigations
Platelet count decreased
|
43.3%
13/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Investigations
Neurphil count decreased
|
36.7%
11/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Investigations
Blood bilirubin increased
|
33.3%
10/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Investigations
White blood cell count decreased
|
30.0%
9/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Investigations
Blood alkaline phosphate increased
|
26.7%
8/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Investigations
Lymmphocyte count decreased
|
23.3%
7/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Investigations
Blood fibrinogen decreased
|
16.7%
5/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Investigations
Activated partial thromboplastin time prolonged
|
10.0%
3/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Investigations
Cd4 lymphocytes decreased
|
10.0%
3/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Investigations
Alanine aminotransferase
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Investigations
Blood creatinine increased
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Investigations
Ejection fraction decreased
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
70.0%
21/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Metabolism and nutrition disorders
Hypophosphotaemia
|
56.7%
17/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
53.3%
16/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Metabolism and nutrition disorders
Hypokalemia
|
46.7%
14/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
40.0%
12/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
10/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.3%
4/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.3%
4/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
10.0%
3/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
10.0%
3/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Metabolism and nutrition disorders
Acidosis
|
6.7%
2/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
6.7%
2/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Metabolism and nutrition disorders
Tumor lysis syndrom
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Musculoskeletal and connective tissue disorders
Muscular wekness
|
10.0%
3/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
2/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Nervous system disorders
Headache
|
13.3%
4/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Nervous system disorders
Seizure
|
10.0%
3/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Nervous system disorders
Dysgeusia
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Nervous system disorders
Encephalopathy
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Nervous system disorders
Intracranial Haemorrhage
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Nervous system disorders
Neuroptahy peripheral
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Psychiatric disorders
Mental status changes
|
13.3%
4/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Psychiatric disorders
Insomnia
|
10.0%
3/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Psychiatric disorders
Confusional state
|
6.7%
2/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Psychiatric disorders
Agitation
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Psychiatric disorders
Delirium
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Psychiatric disorders
Hellucination
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
5/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Renal and urinary disorders
Urinary incontinence
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.3%
4/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
2/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Respiratory, thoracic and mediastinal disorders
Dsypnoea
|
6.7%
2/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
2/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
2/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Vascular disorders
Hypertension
|
6.7%
2/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Vascular disorders
Embolism venous
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
|
Vascular disorders
Hypotension
|
3.3%
1/30 • 12 Months
The remaining 12 participants that did not receive IP were not included in the AE Reporting, causing only 30 / 42 to be at risk".
|
Additional Information
Noelle Frey, MD
Abramson Cancer Center of the University of Pennsylvania
Phone: 215-662-6901
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place