Adults 18 to 100, any sex, with Follicular Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Complete Response Rate (CRR) Per Independent Review Committee (IRC) AssessmentPrimary· 1 year
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 respo
Group
Value
95% CI
CTL019
69.1
58.8 – 78.3
Overall Response Rate (ORR) Per IRC AssessmentSecondary· 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 sc
Group
Value
95% CI
CTL019
86.2
77.5 – 92.4
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
CTL019
Serious: 42/97 (43%)
Deaths: 7/97
Serious adverse events (45 terms)
Reaction
System
CTL019
Cytokine release syndrome
Immune system disorders
—
Pneumonia
Infections and infestations
—
Febrile neutropenia
Blood and lymphatic system disorders
—
Pyrexia
General disorders
—
Neutropenia
Blood and lymphatic system disorders
—
Infusion related reaction
Injury, poisoning and procedural complications
—
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Encephalopathy
Nervous system disorders
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
Anaemia
Blood and lymphatic system disorders
—
Ventricular fibrillation
Cardiac disorders
—
Blindness
Eye disorders
—
Gastrointestinal ulcer
Gastrointestinal disorders
—
Glossitis
Gastrointestinal disorders
—
Nausea
Gastrointestinal disorders
—
Stomatitis
Gastrointestinal disorders
—
Vomiting
Gastrointestinal disorders
—
Catheter site haemorrhage
General disorders
—
Graft versus host disease in gastrointestinal tract
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 7 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03568461.