Therapy of Chronic Lymphocytic Leukemia With Dasatinib (BMS-354825)
Condition: Leukemia; Lymphoma
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Dasatinib (BMS-354825)
Intervention description: 50mg Orally twice daily
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Healthy volunteers: No
Keywords: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Prolymphocytic Leukemia; Leukemia; Lymphoma; Dasatinib; BMS-354825

Summary:

      The goal of this clinical research study is to learn if dasatinib can help to control Chronic
      Lymphocytic Leukemia (CLL). The safety of the drug will also be studied.

      Optional Procedures: You will be asked to have additional blood samples drawn. These samples
      will be used to see how the disease is responding to the drug.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of CLL, Small lymphocytic lymphoma (SLL), or -cell prolymphocytic leukemia
             (T-PLL).

          2. Previously treated with chemotherapy or monoclonal antibodies.

          3. All patients with Rai stage III-IV are eligible. - OR - Patients with Rai stage 0-II
             who meet one or more indication for treatment as defined by the NCI-sponsored Working
             Group are eligible:Massive or progressive splenomegaly; Massive lymph nodes, nodal
             clusters, or progressive lymphadenopathy; Grade 2 or 3 fatigue, fever >/= 100.5
             degrees F, night sweats for > 2 weeks w/o documented infection, presence of weight
             loss >/= 10% over the preceding 6 months; Progressive lymphocytosis with increase in
             lymphocyte count of >/= 50% over a 2-month period or an anticipated doubling time of <
             6 months.

          4. Serum bilirubin less than 2mg/dL, serum creatinine less than 2mg/dL unless abnormality
             is considered due to CLL by investigator.

          5. The Eastern Cooperative Oncology Group (ECOG) Performance Status < 3.

          6. Patients must sign an informed consent indicating they are aware of the
             investigational nature of this study, in keeping with the policies of the hospital.

          7. Sexually active women of childbearing potential must use birth control during study in
             manner that risk of failure is minimized. Prior to study enrollment women of
             childbearing potential must be advised of importance of avoiding pregnancy during
             trial and potential risk factors for unintentional pregnancy. MUST have negative
             pregnancy test. If pregnancy test is positive patient must not receive investigational
             product and must not be enrolled in study. Men enrolled on study should understand
             risks to sexual partner of childbearing potential and practice effective birth
             control.

          8. Inclusion of women and minorities: As per NIH policy, women and members of minorities
             will be included in this protocol as they are referred in the relevant populations.
             There are no exclusions of women or minorities based on the study objectives.

          9. New York Heart Association (NYHA) Class < 3

         10. Patients must sign informed consent.

        Exclusion Criteria:

          1. Pregnant or breast-feeding women are excluded.

          2. Patients may not receive concurrent chemotherapy, radiotherapy, or immunotherapy.
             Localized radiotherapy to an area not compromising bone marrow function does not
             apply, nor do hematopoietic growth factors such as erythropoietin, G-CSF, GM-CSF etc.

          3. Patients must not have untreated or uncontrolled life-threatening infection.

          4. Uncontrolled angina within 3 months; diagnosed or suspected congenital long QT
             syndrome; any history of clinically significant ventricular arrhythmias; prolonged QTc
             interval (> 450 msec); uncontrolled hypertension; significant bleeding disorder
             unrelated to cancer; patients currently taking drugs that are generally accepted to
             have a risk of causing Torsades de Pointes.

          5. Medications that inhibit platelet function (i.e., aspirin, dipyridamole, epoprostenol,
             eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and any non-steroidal
             anti-inflammatory drug) or Anticoagulants (warfarin, heparin/low molecular weight
             heparin [e.g., danaparoid, dalteparin, tinzaparin, enoxaparin]).