At a glance
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Lenalidomide in Combination With Plerixafor in Patients With Previously Treated Chronic Lymphocytic Leukemia
In Brief
A Phase 1 clinical trial evaluating Lenalidomide + Plerixafor (+ Rituximab) for Leukemia, Lymphocytic, Chronic, B-Cell. Completed, enrolled 21 participants across 1 site.
Detailed Summary
In research studies, lenalidomide (also called Revlimid) has shown some response in chronic lymphocytic leukemia (CLL); however, responses are usually partial responses that occur after several months of taking the study drug. It is thought that by adding the drug plerixafor (also called Mozobil) responses may be improved and/or occur sooner. The main purpose of this study is to determine the dose of plerixafor that is safe to use in combination with lenalidomide. The study will also look at the response rates of the combination of lenalidomide and plerixafor and the effect the study drugs have on CLL cells.
Study Details
Timeline
Interventions
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.