Lenalidomide Plus Rituxan for Untreated Mantle Cell Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

July 29, 2011

Primary Completion Date

April 30, 2014

Study Completion Date

July 30, 2023

Conditions
Mantle Cell Lymphoma
Interventions
DRUG

lenalidomide

"Induction phase: 20 mg/day for days 1-21 of a 28-day cycle for 12 cycles. If no excess toxicity is observed the dose will be increased to 25 mg/day.~Maintenance phase: Lenalidomide will be given at 15 mg/day for days 1-21 of a 28-day cycle."

BIOLOGICAL

rituximab

"Induction phase: Rituximab will be administered at 375 mg/m2 per dose for a total of 9 doses. The first 4 doses will be administered weekly starting on day 1 of lenalidomide (e.g. days 1, 8, 15 and 22). Subsequent rituximab doses will be administered for one dose each at weeks 12, 20, 28, 36 and 44.~Maintenance phase: Rituximab at 375 mg/m2 per dose will be administered for one dose every 8 weeks, starting at week 52."

Trial Locations (4)

10065

Weill Cornell Medical College, New York

19104

University of Pennsylvania, Philadelphia

33612

Moffitt Cancer Center, Tampa

60637

University of Chicago, Chicago

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene

INDUSTRY

lead

Weill Medical College of Cornell University

OTHER