Activity & Safety Study of Lenalidomide & Rituximab as Non-chemotherapy Based Therapy on Chronic Lymphocytic Leukemia

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

December 31, 2012

Study Completion Date

September 30, 2013

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

Lenalidomida and Rituximab

"Lenalidomide: Oral use. It will be administered from day 1 to 21 of 28 days cycles in a total of 6 cycles.~Rituximab, intravenous use. The dose will be administered at the standard (375 mg/m2 in the first cycle and 500 mg/m2 in successive cycles).~In the first cycle Rituximab will be administered in two divided doses:100mg/m2 total on day 1 and the rest up to 375mg/m2 on day 2.~If lenalidomide treatment starts on day 1, Rituximab will be administered, in this first cycle, on days -2 (100 mg/m2) and -1 (275 mg/m2).~In the second and subsequent cycles, 500 mg/m2 of Rituximab will be administered on day -1."

Trial Locations (7)

14004

Hospital Universitario Reina Sofía, Córdoba

28033

MD Anderson Internacional España, Madrid

28046

Hospital Universitario La Paz, Madrid

37007

Hospital Clínico de Salamanca, Salamanca

41013

Hospital Virgen del Rocío, Seville

46010

Hospital Clínico Universitario de Valencia, Valencia

50009

Hospital Universitario Miguel Servet, Zaragoza

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

MD Anderson International Spain SA

OTHER