Multi-center Trial of Revlimid® and Rituximab, for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL)

PHASE2UnknownINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

February 29, 2008

Primary Completion Date

February 28, 2011

Study Completion Date

July 31, 2011

Conditions
Chronic Lymphocytic LeukemiaCLLUntreatedFront-lineFirst-LineInitial Therapy
Interventions
DRUG

Lenalidomide and Rituximab

Lenalidomide starting at a low dose and escalated based on patient tolerability 21 days of every cycle. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles. Each patient may receive up to a maximum of 7 cycles of treatment if no progressive disease or significant toxicity.

DRUG

Lenalidomide and Rituximab

Lenalidomide starting at a low dose and escalated based on patient tolerability 21 days of every cycle. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles. Each patient may receive up to a maximum of 7 cycles of treatment if no progressive disease or significant toxicity.

Trial Locations (5)

11040

RECRUITING

Long Island Jewish Medical Center, New Hyde Park

92093

RECRUITING

University of California San Diego, La Jolla

02115

RECRUITING

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston

43210-1240

NOT_YET_RECRUITING

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus

77030-4009

RECRUITING

M. D. Anderson Cancer Center at University of Texas, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

Chronic Lymphocytic Leukemia Research Consortium

NETWORK