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

Study 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.

Primary Outcome

Progression-free survival is defined as the time from randomization to disease progression, new primary of the same type or death, whichever occurs first. Progressive disease is defined as: * Appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size. * \>= 50% increase from nadir in the sum of the product of the diameters of any previously involved nodes or extranodal masses, or in a single involved node or extranodal

Conditions Studied

Interventions

• DRUG Cyclophosphamide
• OTHER Laboratory Biomarker Analysis
• DRUG Doxorubicin Hydrochloride
• DRUG Lenalidomide
• DRUG Prednisone

Study Locations (20)