drugset / Trial / NCT01856192

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

NCT01856192 ↗

Phase 2 Active not recruiting 349 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-08-27
Primary completion
2020-03-26
Completion
2026-12-31

Outcome

Met primary endpoint

registry analysis (superiority test); Arm A (R2CHOP) vs Arm B (RCHOP); p = 0.03; Log Rank NCT01856192 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified — Oral
Background Cyclophosphamide Other / unclassified — Intravenous
Background Doxorubicin Other / unclassified — Intravenous
Background Prednisone Other / unclassified — Oral
Background Rituximab Monoclonal antibody — Intravenous
Background Vincristine Small molecule — Intravenous