Oral lenalidomide with rituximab in relapsed or refractory diffuse large cell, follicular and transformed lymphoma: a phase II clinical trial.

Journal Article (Journal Article)

Lenalidomide-rituximab therapy is effective in grade 1-2 follicular and mantle cell lymphoma, but its efficacy in diffuse large B-cell lymphoma (DLBCL), transformed large cell lymphoma (TL) and grade 3 follicular lymphoma (FLG3) is unknown. In this phase II trial, 45 patients with relapsed or refractory DLBCL (n=32), TL (n=9) or FLG3 (n=4) who had received 1-4 prior lines of treatment were given 20 mg oral lenalidomide on days 1-21 of each 28-day cycle, and intravenous rituximab (375 mg/m(2)) weekly during cycle 1. Grade 3/4 hematological toxicities included neutropenia (53%), lymphopenia (40%), thrombocytopenia (33%), leukopenia (27%) and anemia (18%), with a median follow-up time of 29.1 months (range 14.7-52.0 months). Overall response (OR) rate was 33%; median response duration was 10.2 months. Median progression-free survival (PFS) and overall survival (OS) were 3.7 and 10.7 months, respectively. Nine of the 15 responding patients (three partial response (PR), six complete response (CR)) proceeded with stem cell transplantation (SCT) and were censored at the time of transplantation. When data were analyzed without censoring, median PFS remained 3.7 months and response duration increased to 30.9 months. Rituximab plus oral lenalidomide is well tolerated and effective for patients with relapsed/refractory DLBCL and TL. SCT after lenalidomide-rituximab is associated with prolonged response duration.

Full Text

Duke Authors

Cited Authors

  • Wang, M; Fowler, N; Wagner-Bartak, N; Feng, L; Romaguera, J; Neelapu, SS; Hagemeister, F; Fanale, M; Oki, Y; Pro, B; Shah, J; Thomas, S; Younes, A; Hosing, C; Zhang, L; Newberry, KJ; Desai, M; Cheng, N; Badillo, M; Bejarano, M; Chen, Y; Young, KH; Champlin, R; Kwak, L; Fayad, L

Published Date

  • September 2013

Published In

Volume / Issue

  • 27 / 9

Start / End Page

  • 1902 - 1909

PubMed ID

  • 23545991

Electronic International Standard Serial Number (EISSN)

  • 1476-5551

Digital Object Identifier (DOI)

  • 10.1038/leu.2013.95


  • eng

Conference Location

  • England