Fludarabine, Rituximab, and Lenalidomide in Minimally Treated/Untreated Patients With Chronic Lymphocytic Leukemia (CLL)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

April 30, 2013

Study Completion Date

November 30, 2016

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

lenalidomide

2.5 mg orally (PO) daily, Days 8-28, Cycle 1; 5.0 mg PO daily, Days 8-28 Cycles 2-6

DRUG

Rituximab

375 mg/m2 Cycle 1 (split over Day 1 \& Day 2); 500 mg/m2 Day 1 of Cycles 2-6

DRUG

Fludarabine

25 mg/m2 on Days 1, 2, and 3

Trial Locations (6)

20817

Center for Cancer and Blood Disorders, Bethesda

National Capital Clinical Research Consortium, Bethesda

29210

South Carolina Oncology Associates, PA, Columbia

32804

Florida Hospital Cancer Institute, Orlando

33901

Florida Cancer Specialists, Fort Myers

37023

Tennessee Oncology, PLLC, Nashville

Sponsors
All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

collaborator

Genentech, Inc.

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER