Lenalidomide + Plerixafor in Previously Treated Chronic Lymphocytic Leukemia (CLL)

PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2015

Conditions
Leukemia, Lymphocytic, Chronic, B-Cell
Interventions
DRUG

Lenalidomide + Plerixafor (+ Rituximab)

"1. Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.~2. Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.~3. Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) \<100.0 x 109 / L.~4. Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:~ * Cohort 1: 0.24 mg/kg~ * Cohort 2: 0.32 mg/kg~ * Cohort 3: 0.42 mg/kg~ * Cohort 4: 0.54 mg/kg~5. Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.~6. Subjects will then continue single agent lenalidomide until disease progression."

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

collaborator

Genzyme, a Sanofi Company

INDUSTRY

lead

David Rizzieri, MD

OTHER

NCT01373229 - Lenalidomide + Plerixafor in Previously Treated Chronic Lymphocytic Leukemia (CLL) | Biotech Hunter | Biotech Hunter