Spots Global Cancer Trial Database for Lenalidomide Plus Rituximab (R) in Non Follicular NHL

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Trial Identification

Brief Title: Lenalidomide Plus Rituximab (R) in Non Follicular NHL

Official Title: Phase II Study of Lenalidomide in Combination With Rituximab (R) for the Treatment of Indolent Non Follicular Non Hodgkin Lymphoma (NHL).

Study ID: NCT01830478

Conditions

Indolent Non Hodgkin Lymphoma

Interventions

Lenalidomide

Rituximab

Study Description

Brief Summary: The purpose of this study is to determine whether lenalidomide in association with rituximab is effective in the treatment of patients with indolent non follicular NHL relapsed after \>=2, but less than 4 prior lines of (immuno)chemotherapy.

Detailed Description: Single arm, multicenter, open-label study divided in two phases: 1. Induction phase; 2. Follow-up phase. Enrolled patients will start the induction phase and receive the courses of R-Lenalidomide. At the end of the third cycle of R-Lenalidomide (week 12 of the study), the patients will be evaluated for tumor response (complete assessment); the patients with Progressive Disease (PD) will be withdrawn of the study. Two weeks after the end last courses of R-Lenalidomide (week 26 of the study) patients will be evaluated for tumor response (complete assessment). Patients with Complete Response (CR) and Partial Response (PR), and with a stable disease will undergo the follow up phase, while patients with PD will be withdrawn of the study.