Lenalidomide + Plerixafor in Previously Treated Chronic Lymphocytic Leukemia (CLL)
Condition: Leukemia, Lymphocytic, Chronic, B-Cell
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Lenalidomide + Plerixafor (+ Rituximab)
Intervention description: Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.
Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.
Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.
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
Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.
Subjects will then continue single agent lenalidomide until disease progression.
Intervention MeSH terms: Plerixafor; Rituximab; Lenalidomide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Lymphocytic Leukemia; CLL

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of chronic lymphocytic leukemia (CLL) or Small
             lymphocytic lymphoma (SLL) as established by the National Cancer Institute (NCI)
             Working Group Response Criteria (NCI 96 Criteria).

          -  Received one or more prior therapies for CLL.

          -  Subjects must have symptomatic disease requiring therapy as defined by the protocol.

          -  >/= 4 weeks from prior cancer therapy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of </= 2.

          -  All study subjects must be registered into the mandatory RevAssist® program, and be
             willing and able to comply with the requirements of RevAssist®.

        Exclusion Criteria:

          -  Prolymphocytic leukemia (PLL).

          -  Richter's (large cell) transformation.

          -  Prior allogeneic transplant within 12 months or prior allogeneic transplant > 12
             months currently receiving immunosuppressants.

          -  Active autoimmune hemolytic anemia.

          -  Central nervous system (CNS) involvement.

          -  Chronic enteral corticosteroids > 10mg prednisone or equivalent.

          -  Evidence of laboratory tumor lysis syndrome (TLS) by Cairo-Bishop Definition of Tumor
             Lysis Syndrome

          -  Use of any other experimental drug or therapy within 28 days of baseline

          -  Major surgery within 28 days of baseline.

          -  Known hypersensitivity to thalidomide.

          -  The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs.

          -  Any prior use of lenalidomide.

          -  Known seropositive for or active viral infection with human immunodeficiency virus
             (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).