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Clinical Trial 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.


Clinical Trial 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patients will be evaluated for tumor response (complete assessment); the patients with Progressive Disease (PD) will be withdrawn of the study.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and Partial Response (PR), and with a stable disease will undergo the follow up phase, while patients with PD will be withdrawn of the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01830478
Study type Interventional
Source Gruppo Italiano Studio Linfomi
Contact
Status Unknown status
Phase Phase 2
Start date April 2009
Completion date October 2014

See also
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