A randomized, open-label, multi-center phase III trial comparing tisagenlecleucel to standard of care in adult participants with relapsed or refractory follicular lymphoma

Phase 1

Recruiting

• Conditions: Adult patients with follicular B-cell non-Hodgkin lymphoma grade 1-3A, relapsed or refractory after at least two prior lines of systemic therapy; MedDRA version: 21.1Level: PTClassification code: 10061170Term: Follicle centre lymphoma follicular grade I II III Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-503452-27-00
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-28
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified