A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma

Launched by NOVARTIS PHARMACEUTICALS · May 24, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called tisagenlecleucel for adults with relapsed or refractory follicular lymphoma, which is a type of cancer that affects the lymphatic system. The trial aims to see how well tisagenlecleucel works compared to the standard treatment currently available. If you or a loved one has follicular lymphoma that has returned or has not responded to previous treatments, you might be eligible to participate. Key eligibility criteria include being at least 18 years old, having a confirmed diagnosis of certain grades of follicular lymphoma, and having an active disease that can be measured through imaging tests.

Participants in this trial can expect to undergo a process called leukapheresis, where some of their blood cells are collected to prepare for the new treatment. The trial is currently recruiting, meaning there are opportunities to join, and it is open to all genders. Before joining, participants will go through a screening process to ensure they meet all the necessary health criteria. It's important to discuss with a healthcare provider to understand more about the trial and what it involves, as well as to review any specific medical conditions that might affect eligibility.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years at the date of signing the informed consent form.
• • 2. Follicular lymphoma grade 1, 2, or 3A confirmed histologically after latest relapse (local assessment).
• • 3. Relapsed or refractory disease after a second or later line of systemic therapy including an anti-CD20 antibody and an alkylating agent.
• • 4. 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.
• • 5. ECOG performance status of 0, 1 or 2 at screening.
• • 6. Adequate hematologic, renal, hepatic and pulmonary organ function at screening.
• • 7. Must meet the institutional criteria to undergo leukapheresis (unless historical leukapheresis is available).
• • 8. Must be eligible for treatment with the selected standard of care regimen.
• Exclusion Criteria:
• • 1. Follicular lymphoma grade 3B or evidence of histologic transformation.
• • 2. Prior treatment with anti-CD19 therapy, gene therapy, or adoptive T-cell therapy.
• • 3. Active CNS involvement by malignancy.
• • 4. Clinically significant active infection, presence of Human immunodeficiency virus (HIV) antibody or active hepatitis B or C.
• • 5. Active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome).
• • 6. Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to randomization.
• • 7. 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