LMBA02 Protocol for Patients With a Burkitt Lymphoma

Phase 3 Unknown 260 enrolled Gustave Roussy, Cancer Campus, Grand Paris

RandomizedSingle-groupOpen-labelTreatment

Summary

To explore in a multicenter international prospective randomized study (phase III) whether rituximab combined with the standard French LMB chemotherapy scheme results in a higher rate of EFS than the LMB chemotherapy scheme alone in patients older than 18 years with Burkitt lymphoma or ALL 3.

Timeline

Start: 2004-10
Primary completion: —
Completion: —

Outcome

Met primary endpoint

paper patients in the rituximab group achieved better 3 year EFS (75% [95% CI 66-82]) than did those in the no rituximab group PMID 27080498 ↗

paper log-rank p stratified by treatment group=0·024 PMID 27080498 ↗

Publications

Ribrag V, Koscielny S, Bosq J, Leguay T, Casasnovas O, Fornecker LM, Recher C, Ghesquieres H, Morschhauser F, Girault S, Le Gouill S, Ojeda-Uribe M, Mariette C, Cornillon J, Cartron G, Verge V, Chassagne-Clement C, Dombret H, Coiffier B, Lamy T, Tilly H, Salles G. Rituximab and dose-dense chemotherapy for adults with Burkitt's lymphoma: a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Jun 11;387(10036):2402-11. doi: 10.1016/S0140-6736(15)01317-3. Epub 2016 Apr 11.

Drugs

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