A Phase 3B Randomized Study of Lenalidomide (CC-5013) Plus Rituximab Maintenance Therapy Followed by Lenalidomide Single-agent Maintenance Versus Rituximab Maintenance in Subjects With Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma, NCT01996865
Purpose of the Clinical Research Trial
This Phase 3B multicenter, randomized (stratified by histology, lines of anti-lymphoma therapy and age), open label study will enroll subjects with relapsed/refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) or mantle cell lymphoma (MZL). All subjects will receive 12 Cycles of lenalidomide plus rituximab induction therapy.
The study is designed to compare the efficacy and safety of two maintenance regimens following induction therapy. Subjects will be randomized at study start to lenalidomide plus rituximab combination therapy (for 18 Cycles) followed by lenalidomide single-agent maintenance (to progression; Arm A, experimental) versus rituximab single-agent maintenance (for 18 Cycles; Arm B, control).
The study is divided into a Screening Period, a Treatment Period (induction and maintenance), and a Follow up Period. Approximately 500 subjects are planned to be randomized.
More Details on This Lymphoma Clinical Trial
13064 / CC-5013-NHL-008 / NCT01996865 / Call PM 7-26-2018
TRIAL AVAILABLE AT THESE LOCATIONS:
All RMCC Locations