Trial Outcomes & Findings for Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma (NCT NCT03568461)

Last Updated: 2025-10-07

Results Overview

Complete response rate was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) recorded from tisagenlecleucel infusion until progressive disease or start of new anticancer therapy, whichever came first. CRR was determined by an independent review committee (IRC) and was based on Lugano 2014 classification response criteria. The radiological response is first obtained from CT and PET studies according to the Lugano 2014 criteria. CT response is based on anatomical measurements of index/non-index/new lesions and spleen length. The possible response outcomes are complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). PET response based on a 5-point scale (5PS) or Deauville score. The possible outcomes for PET response are complete metabolic response (CMR), partial metabolic response (PMR), no metabolic response (NMR), or progressive metabolic disease (PMD).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

98 participants

Primary outcome timeframe

1 year

Results posted on

2025-10-07

Participant Flow

90 patients were planned, 98 patients were enrolled and 97 patients were infused with tisagenlecleucel.

During the Screening phase and prior to enrolment into the study, a patient's white blood cells were collected via leukapheresis.

Participant milestones

Participant milestones
Measure	CTL019 All patients who received tisagenlecleucel infusion
Overall Study STARTED	98
Overall Study Treated	97
Overall Study Discontinued Prior to Infusion With Tisagenlecleucel	1
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	CTL019 All patients who received tisagenlecleucel infusion
Overall Study Death	7
Overall Study Physician Decision	5
Overall Study Subject decision	5
Overall Study Lost to Follow-up	1

Baseline Characteristics

Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CTL019 n=98 Participants All patients who received tisagenlecleucel infusion
Age, Continuous	56.5 years STANDARD_DEVIATION 10.34 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants
Race/Ethnicity, Customized White	74 Participants n=5 Participants
Race/Ethnicity, Customized Asian: Japanese	9 Participants n=5 Participants
Race/Ethnicity, Customized Asian: Indian	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian: Missing (participants identified as Asian but with no other details provided)	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Missing (No race/ethnicity provided)	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Efficacy analysis set (EAS): All the patients who received tisagenlecleucel, and had measurable disease at baseline per IRC. Non-measurable disease at baseline is defined as absence of index lesion at baseline disease evaluation (i.e. no disease at baseline).

Outcome measures

Outcome measures
Measure	CTL019 n=94 Participants All patients who received tisagenlecleucel infusion
Complete Response Rate (CRR) Per Independent Review Committee (IRC) Assessment	69.1 Percentage of participants Interval 58.8 to 78.3

SECONDARY outcome

Timeframe: 1 year

Overall response rate is defined as the percentage of participants with a best overall disease response of complete response (CR) or partial response (PR). Response was evaluated per Lugano 2014 classification response criteria. The radiological response is first obtained from CT and PET studies according to the Lugano 2014 criteria. CT response is based on anatomical measurements of index/non-index/new lesions and spleen length. The possible response outcomes are complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). PET response based on a 5-point scale (5PS) or Deauville score. The possible outcomes for PET response are complete metabolic response (CMR), partial metabolic response (PMR), no metabolic response (NMR), or progressive metabolic disease (PMD).

Outcome measures

Outcome measures
Measure	CTL019 n=94 Participants All patients who received tisagenlecleucel infusion
Overall Response Rate (ORR) Per IRC Assessment	86.2 Percentage or participants Interval 77.5 to 92.4

SECONDARY outcome

Timeframe: 1 year

Duration of response (DOR) applied only to participants whose best overall disease response was CR or PR. It is defined as the time from the date of first documented disease response (CR or PR) to the date of first documented progression or death due to follicular lymphoma (FL).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Time from tisagenlecleucel infusion to first documented disease progression or death due to any cause

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Time from tisagenlecleucel infusion to death due to any cause

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Transgene concentration as detected by qPCR in target tissue

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

The maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration (% or copies/ µg)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

The time to reach maximum (peak) peripheral blood or other body fluid drug concentration after single dose administration (days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

The AUC from time zero to day 28, in peripheral blood (%\*days or days\*copies/ µg)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

The AUC from time zero to day 84, in peripheral blood (%\*days or days\*copies/ µg)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

The half-life associated with the elimination phase slope of a semi logarithmic concentration-time curve (days) in peripheral blood

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

The last observed measureable timepoint after dose administration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

In vivo cellular kinetics of CD3+ tisagenlecleucel cells detected by flow cytometry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Antibody titers specific to the tisagenlecleucel molecule prior to and following infusion.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Presence of T lymphocytes activated by the tisagenlecleucel protein

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Effect of tisagenlecleucel therapy on Patient reported outcomes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Effect of tisagenlecleucel therapy on Patient reported outcomes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Effect of tisagenlecleucel therapy on Patient reported outcomes

Outcome measures

Outcome data not reported

Adverse Events

CTL019

Serious events: 42 serious events

Other events: 94 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	CTL019 n=97 participants at risk All patients who received tisagenlecleucel infusion
Blood and lymphatic system disorders Anaemia	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	6.2% 6/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	2.1% 2/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 fibrillation	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Blindness	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Gastrointestinal ulcer	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Glossitis	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 haemorrhage	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	3.1% 3/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	19.6% 19/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Graft versus host disease in gastrointestinal tract	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Bacteraemia	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 COVID-19	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 COVID-19 pneumonia	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Diverticulitis	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Human herpesvirus 6 encephalitis	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Localised infection	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Lower respiratory tract infection	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Perirectal abscess	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	8.2% 8/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 haemophilus	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Progressive multifocal leukoencephalopathy	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Pseudomonal bacteraemia	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	2.1% 2/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Failure to thrive	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Muscle spasms	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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) Basal cell carcinoma	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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) Bowen's disease	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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) Malignant melanoma	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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) Squamous cell carcinoma	2.1% 2/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	2.1% 2/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Immune effector cell-associated neurotoxicity syndrome	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Syncope	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Dyspnoea	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	2.1% 2/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Pneumothorax	1.0% 1/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	CTL019 n=97 participants at risk All patients who received tisagenlecleucel infusion
Investigations Neutrophil count decreased	17.5% 17/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	10.3% 10/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 SARS-CoV-2 test negative	6.2% 6/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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% 6/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	21.6% 21/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	7.2% 7/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Hyperglycaemia	5.2% 5/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	9.3% 9/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Hypomagnesaemia	8.2% 8/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	9.3% 9/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	10.3% 10/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Back pain	8.2% 8/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Muscle spasms	6.2% 6/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	8.2% 8/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	5.2% 5/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	7.2% 7/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	24.7% 24/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Insomnia	6.2% 6/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	12.4% 12/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Dyspnoea	5.2% 5/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	5.2% 5/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Productive cough	5.2% 5/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	5.2% 5/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	9.3% 9/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	6.2% 6/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	5.2% 5/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	8.2% 8/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Anaemia	24.7% 24/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	8.2% 8/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Leukopenia	8.2% 8/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	8.2% 8/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	42.3% 41/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	19.6% 19/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	7.2% 7/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	14.4% 14/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	21.6% 21/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	14.4% 14/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	8.2% 8/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Asthenia	6.2% 6/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	7.2% 7/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	16.5% 16/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	16.5% 16/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	30.9% 30/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	14.4% 14/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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 Nasopharyngitis	6.2% 6/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	5.2% 5/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	7.2% 7/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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	9.3% 9/97 • Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 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

Email: [email protected]

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 pooled data (i.e. data from all sites) in clinical trial or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER