NCT01830478

Lenalidomide Plus Rituximab (R) in Non Follicular NHL

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Gruppo Italiano Studio Linfomi · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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will be evaluated for tumor response (complete assessment); the patients with Progressive Disease (PD) will be withdrawn of the study.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and Partial Response (PR), and with a stable disease will undergo the follow up phase, while patients with PD will be withdrawn of the study.

Conditions

• Indolent Non Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Lenalidomide	Lenalidomide 20 mg p.o. once daily, days 1-21 every 28 days, for 6 cycles
DRUG	Rituximab	Rituximab 375 mg/m2 intravenously, day 14 of every course for 6 cycles

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-12-01
• Completion: 2014-10-01
• First posted: 2013-04-12
• Last updated: 2013-04-12

Locations

1 site across 1 country: Italy