drugset / Trial / NCT01996865

Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.

NCT01996865

Phase 3 Completed 503 enrolled Celgene Corporation
RandomizedParallel-groupOpen-labelTreatment

Summary

Follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) are distinct histologic types of B-cell NHL. Lenalidomide is an immunomodulatory agent with direct and immune-mediated mechanisms of action, as well as clinical activity in NHL. Recent studies in frontline and relapsed/refractory NHL show high activity for lenalidomide plus rituximab (R2), supporting further study of this combination.

Timeline

Start
2014-04-01
Primary completion
2024-05-11
Completion
2024-09-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified 10 mg Oral
Subject Lenalidomide Other / unclassified 20 mg Oral
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications