Sapacitabine, Cyclophosphamide, Rituximab for Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma (CLL/SLL) With Deletion (11q22-23)
Condition: Leukemia
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Cyclophosphamide; Rituximab; Sapacitabine
Intervention description: 250 mg/m2 by vein (IV) over 30 minutes, 2 hours following the dose of Sapacitabine on days 1, 2, and 3 of each 28 day course.; 375 mg/m2 by vein over 6 - 8 hours on day 3 of course 1 after cyclophosphamide, then at 500 mg/m2 on day 1, after cyclophosphamide for subsequent courses. Each course is 28 days.; 350 mg flat dose by mouth in the morning of days 1,2, and 3 of each 28 day course.
Intervention MeSH terms: Cyclophosphamide; Rituximab; Sapacitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Lymphocytic Leukemia; CLL; Small Lymphocytic Lymphoma; SLL; Cyclophosphamide; Rituximab; Sapacitabine; Cytoxan; Neosar; Rituxan

Summary:

      The goal of this clinical research study is to learn if sapacitabine given in combination
      with 2 standard drugs (cyclophosphamide and rituximab) can help to control CLL and SLL. The
      safety of this drug combination will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have a diagnosis of CLL/SLL and be previously treated

          2. Patients must have had Fluorescence in situ Hybridization (FISH) evaluation of
             leukemia cells within 3 months without intervening treatment demonstrating deletion
             11q22-23

          3. Patients must have an indication for treatment by 2008 International Workshop on
             Chronic Lymphocytic Leukemia (IWCLL) Criteria

          4. Age >/= 18 years

          5. Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status </= 2

          6. Adequate renal and hepatic function as indicated by all the following: serum
             creatinine </= 2 mg/dL AND; alanine aminotransferase (ALT) </= 2.5 times upper limit
             of normal; AND total bilirubin </= 2.5 times upper limit of normal

          7. Patients must have an Absolute neutrophil count (ANC) >/= 500/uL, Hemoglobin (HGB) >/=
             8 gm/dL, Platelets (PLT) count >/= 20K/uL, unless attributed to marrow infiltration
             with CLL

          8. Patients must give written informed consent

          9. Patients of childbearing potential (females who have not been postmenopausal for at
             least 12 consecutive months or who have not undergone previous surgical sterilization
             or males who have not been surgically sterilized) must be willing to practice birth
             control during the study

        Exclusion Criteria:

          1. Pregnant or breast-feeding females

          2. Significant co-morbidity indicated by major organ system dysfunction

          3. Active infection, uncontrolled with intravenous antibiotics

          4. Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenia purpura
             (ITP)

          5. Treatment including chemotherapy, chemoimmunotherapy, monoclonal antibody therapy,
             radiotherapy, high-dose corticosteroid therapy (prednisone >/= 60 mg daily, or
             equivalent), or immunotherapy within 3 weeks prior to enrollment or concurrent with
             this trial