Trial of Bendamustine, Lenalidomide and Rituximab in Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL)

PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
Chronic Lymphocytic LeukemiaNon-Hodgkin's Lymphoma
Interventions
DRUG

bendamustine and lenalidomide

Lenalidomide is given daily orally for one week followed by bendamustine HCL 90 mg/m2 IV over 30 to 60 minutes on days 1 and 2 in combination with lenalidomide, given orally, in dose-escalating cohorts. After a maximum of 6 cycles of combination therapy with bendamustine and lenalidomide, lenalidomide monotherapy is continued for an additional 6 cycles as tolerated or until disease progression.

DRUG

BL-NHL

Bendamustine HCL 90 mg/m2 given intravenously over 30 to 60 minutes on days 1 and 2 in combination with lenalidomide, given orally, in dose-escalating cohorts. After a maximum of 6 cycles of combination therapy with bendamustine and lenalidomide, lenalidomide monotherapy is continued for an additional 6 cycles as tolerated or until disease progression.

DRUG

BLR-CLL

Lenalidomide is given orally for 7 days followed by rituximab 375 mg/m2 on day 1 in addition to bendamustine 90 mg/m2 intravenously over 30-60 minutes on days 1 and 2 and lenalidomide orally daily every 28 days for a total of 6 cycles. After 6 cycles of bendamustine, lenalidomide and rituximab, lenalidomide monotherapy is administered as continued therapy for an additional 6 cycles as tolerated or until disease progression.

DRUG

BLR-NHL

Rituximab 375 mg/m2 is given on day 1 on day 1 in addition to bendamustine 90 mg/m2 intravenously over 30-60 minutes on days 1 and 2 and lenalidomide orally daily every 28 days for a total of 6 cycles. After 6 cycles of bendamustine, lenalidomide and rituximab, lenalidomide monotherapy is administered as continued therapy for an additional 6 cycles as tolerated or until disease progression.

Trial Locations (1)

20007

Georgetown University Hospital/Lombardi Cancer Center, Washington D.C.

Sponsors
All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

collaborator

Cephalon

INDUSTRY

lead

Georgetown University

OTHER

NCT00864942 - Trial of Bendamustine, Lenalidomide and Rituximab in Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL) | Biotech Hunter | Biotech Hunter