NCT00901615

Lenalidomide and R-CHOP in B-cell Lymphoma

A Phase IB Study of Escalating Doses of REVLIMID in Association With R-CHOP (R2-CHOP) in the Treatment of B-cell Lymphoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Lymphoma Study Association · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the recommended dose (RD) of lenalidomide (Revlimid) when administered in association with R-CHOP (rituximab (R), cyclophosphamide, doxorubicin, vincristine and prednisone).

Detailed description

The study is a dose escalation study of lenalidomide (Revlimid) administered orally during 14 days in combination with fixed doses of rituximab (R), cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks (R-CHOP 21) in patients with B-cell lymphoma.

Conditions

• Lymphoma, Large B-Cell, Diffuse
• Follicular Lymphoma
• Mantle Cell Lymphoma
• Marginal Zone Lymphoma

Interventions

Type	Name	Description
DRUG	Lenalidomide and R-CHOP	Lenalidomide dose administered orally during 14 days in combination with 6 courses of fixed doses of R-CHOP 21.

Timeline

• Start date: 2009-01-06
• Primary completion: 2010-11-19
• Completion: 2015-11-23
• First posted: 2009-05-14
• Last updated: 2018-08-23

Locations

5 sites across 1 country: France