Follicular Lymphoma IV/SC Rituximab Therapy (FLIRT)

Phase 3 Completed 221 enrolled The Lymphoma Academic Research Organisation Roche Pharma AG · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Patient will receive either one infusion of rituximab IV and seven administrations of rituximab SC (experimental arm) or four infusions of rituximab IV (standard arm). The hypothesis is that the use of rituximab by sub cutaneous route and the scheme of administration could: * optimize rituximab exposure leading to improve response rate * increase adaptative response and then improve long-term control disease.

Timeline

Start: 2015-02-02
Primary completion: 2021-06-29
Completion: 2021-06-29

Outcome

Met primary endpoint

paper The primary end point was met: the 4-year PFS was 58.1% PMID 37071836 ↗

paper hazard ratio, 0.585 [0.393 to 0.871]; P = .0076 PMID 37071836 ↗

Publications

Cartron G, Bachy E, Tilly H, Daguindau N, Pica GM, Bijou F, Mounier C, Clavert A, Damaj GL, Slama B, Casasnovas O, Houot R, Bouabdallah K, Sibon D, Fitoussi O, Morineau N, Herbaux C, Gastinne T, Fornecker LM, Haioun C, Launay V, Araujo C, Benbrahim O, Sanhes L, Gressin R, Gonzalez H, Morschhauser F, Ternant D, Xerri L, Tarte K, Pranger D. Randomized Phase III Trial Evaluating Subcutaneous Rituximab for the First-Line Treatment of Low-Tumor Burden Follicular Lymphoma: Results of a LYSA Study. J Clin Oncol. 2023 Jul 1;41(19):3523-3533. doi: 10.1200/JCO.22.02327. Epub 2023 Apr 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous
Subject	Rituximab	Monoclonal antibody	1400 mg	Intravenous