BENITIONSClinical Trial Intelligence

Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma

Phase 2 Active, not recruiting NCT01856192

ConditionAnn Arbor Stage II Diffuse Large B-Cell Lymphoma, Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma
PhasePhase 2
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment349 participants
InterventionsCyclophosphamide, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Lenalidomide, Prednisone
Start dateAug 27, 2013
Completion dateMar 26, 2020
Results postedJun 3, 2021

Summary

This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether rituximab and combination chemotherapy are more effective when given with or without lenalidomide in treating patients with diffuse large B cell lymphoma.

3-year Progression-free Survival Rate

Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10, 3-year PFS rate reported · proportion of participants

Arm A (R2CHOP)0.727 proportion of participants
Arm B (RCHOP)0.615 proportion of participants
p-value0.03

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