Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL
Condition: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
MeSH terms: Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Bendamustine; Rituximab; Lenalidomide
Intervention description: 90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles; 375 mg/m2 Day 1 every 28 days for 6 cycles; 5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol.
Intervention MeSH terms: Rituximab; Lenalidomide; Bendamustine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CLL; SLL

Summary:

      The purpose of this research is to evaluate a new combination of chemotherapy drugs for
      CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an
      intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill).

      The purpose of this study is to see if giving the chemotherapy pill lenalidomide after
      treatment with bendamustine and rituximab is able to prolong the period of time before the
      cancer starts growing again and causing symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed,CLL/SLL, documented relapsed or refractory disease after at
             least one prior chemotherapy regimen.

          -  In cases of SLL, patients must have at least one bidimensionally measurable lesion at
             least ≥1.5 cm measured in one dimension.

          -  ECOG performance status of 0-2 at study entry

          -  Laboratory test results within these ranges: ANC <=1500/μL, Platelet count <=
             100,000/μL. Patients with ANC <1500/μL or plt <100,000/μL with splenomegaly or
             extensive bone marrow involvement as the etiology for their cytopenias are eligible.

          -  creatinine clearance of >60 mL/min as determined by the Cockcroft-Gault calculation.

          -  Total bilirubin <= 2X upper limit laboratory normal (ULN). Patients with
             non-clinically significant elevations of bilirubin due to Gilbert's disease are not
             required to meet these criteria.

          -  Serum transaminases AST (SGOT) and ALT (SGPT) <=5x ULN, Serum alkaline phosphatase ≤5
             X ULN.

          -  Disease free of prior malignancies for ≥ 2 years with the exception of basal or
             squamous cell skin carcinoma, carcinoma "in situ" of the breast or cervix, or
             localized prostate cancer (treated definitively with hormone therapy, radiotherapy, or
             surgery).

          -  Patients may have received prior therapy with bendamustine or lenalidomide, but must
             not have disease that is refractory to bendamustine or lenalidomide.

          -  Prior therapy with rituximab is permitted, even in the setting of rituximab refractory
             disease.

        Exclusion Criteria:

          -  Has received >5 lines of prior therapy for their disease. Re-treatment with an
             identical regimen does not count as a new regimen.

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form or comply with the
             protocol treatment.

          -  Pregnant or breast feeding females. Lactating females must agree not to breast feed
             while taking lenalidomide.

          -  Prior history or current evidence of central nervous system or leptomeningeal
             involvement.

          -  Use of any other experimental drug or therapy 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.

          -  Known to be positive for HIV or infectious hepatitis, type B or C.