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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
David Rizzieri, MD
Study ID
NCT01373229
Phase
PHASE1
Status
Completed

Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenalidomide + Plerixafor (+ Rituximab) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 31, 2012
Status verified
Jul 2017
Primary completion
Mar 31, 2014
Completion
Mar 31, 2015

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: 4-16 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NC

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