Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18 - 100
Clinical summary
Summary
The purpose of this study is to compare the clinical benefit of tisagenlecleucel, which is an autologous cellular immunotherapy, to standard of care therapy in people with relapsed or refratory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.
Eligible participants will be randomly allocated to one of two treatment arms.
In Arm A, participants will receive treatment with tisagenlecleucel (0.6 tp 6 x 10^8 CAR-positive T-cells) which will be given as a single infusion.
In Arm B, participants will receive standard of care treament of either R2 or R-CHOP chemotherapy, based on investigator choice.
Conditions
This trial is treating people with follicular lymphoma
Eligibility
Inclusion
- Age ≥ 18 years at the date of signing the informed consent form.
- Follicular lymphoma grade 1, 2, or 3A confirmed histologically after latest relapse (local assessment).
- Relapsed or refractory disease after a second or later line of systemic therapy including an anti-CD20 antibody and an alkylating agent.
- Disease that is both active on Positron emission tomography (PET) scan (defined as a score of 4 or 5 on the Deauville 5-point scale) and measurable on Computed tomography (CT) scan.
- ECOG performance status of 0, 1 or 2 at screening.
- Adequate hematologic, renal, hepatic and pulmonary organ function at screening.
- Must meet the institutional criteria to undergo leukapheresis (unless historical leukapheresis is available).
- Must be eligible for treatment with the selected standard of care regimen.
Exclusion
- Follicular lymphoma grade 3B or evidence of histologic transformation.
- Prior treatment with anti-CD19 therapy, gene therapy, or adoptive T-cell therapy.
- Active CNS involvement by malignancy.
- Clinically significant active infection, presence of Human immunodeficiency virus (HIV) antibody or active hepatitis B or C.
- Active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome).
- Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to randomization.
- Clinically significant cardiovascular conditions such as acute coronary syndrome, significant cardiac arrhythmias, heart failure or decreased LVEF.
Other protocol defined inclusion/exclusion criteria may apply
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You are currently being treated on a clinical trial.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Novartis Pharmaceuticals
Scientific Title
A Randomized, Open-label, Multi-center Phase III Trial Comparing Tisagenlecleucel to Standard of Care in Adult Participants With Relapsed or Refractory Follicular Lymphoma (FL)
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