A phase I study of escalating doses of lenalidomide combined with R-CHOP (R2-CHOP) for front-line treatment of B-cell lymphomas.

TPS297 Background: R-CHOP has become the standard front-line treatment of most patients (pts) with B-cell lymphoma. Single drug studies of lenalidomide in relapsed/refractory lymphoma have demonstrated a significant activity in both indolent and aggressive lymphomas. Methods: This phase I study was designed to determine the recommended dose of lenalinomide when given in combination with R-CHOP-21 for patients with previously untreated B-cell lymphoma. Pts with previously untreated CD20+ B-cell lymphoma received R-CHOP (rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, all on day 1, prednisone 100 mg/m2 days 1-5) given every 3 weeks for 6 cycles. Oral lenalidomide was administered on days 1-14 of each cycle, and was dose escalated at 5 mg per dose level according to a standard 3+3 design. Pegfilgrastim was administered on day 4 and oral aspirin (100 mg) was given daily during the treatment. Maximum tolerated dose (MTD) was determined by the number of dose limitin...