Lenalidomide in Comb w/Rituximab for Pts w/CD5+/CD20+ Hem Malignancies Who Relapse/Progress After Rituximab

PHASE2CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

February 28, 2014

Study Completion Date

August 31, 2015

Conditions
Lymphocytic LeukemiaMantle Cell Lymphoma
Interventions
DRUG

Lenalidomide

Lenalidomide was administered orally with escalating doses on 28-days cycles. The first cycle was administered with a starting dose of 2.5 mg daily on days 1-7, 5mg on days 8-14 and 10 mg on days 15-21, followed by seven days off. On cycle 2 and beyond lenalidomide was administered at 20 mg daily on days 1-21.

DRUG

Rituximab

Rituximab was administered at 375 mg/m\^2 intravenously on a weekly basis for the first cycle starting on day 15. Subsequent rituximab doses were administered on day one of cycle 2 and beyond, every 4 weeks. Doses were repeated on 28-day cycles until disease progression or unacceptable toxicity, but were planned for 12 cycles.

Trial Locations (2)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

33805

Center for Cancer Care & Research/Watson, Lakeland

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER