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Active Clinical Trials: Hematology- Chronic Lymphocytic Leukemia (CLL)

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ProtocolTitle
MCCRC-RC0783Randomized Phase II Trial of Pentostatin, Cyclophosphamide, and Rituximab With or Without Concurrent Avastin for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL). (1670)
  • Eligibility: click to view information

    **Open To All Components**

    DISEASE CHARACTERISTICS:

    Diagnosis of 1 of the following:

    Biopsy proven small lymphocytic lymphoma (SLL)
    Chronic lymphocytic leukemia (CLL)* as evidenced by the following criteria:

    Peripheral blood lymphocyte count > 5,000/mm³ consisting of small to moderate size lymphocytes
    Immunophenotyping consistent with CLL, defined by the following:

    The predominant population of lymphocytes share both B-cell antigens (CD19, CD20, or CD23) as well as CD-5 in the absence of other pan-T-cell markers (CD-3 or CD-2)
    Dim surface immunoglobulin expression
    Exclusively kappa and lambda light chains
    Negative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy samples NOTE: *Splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL
    Has e 1 of the following indications** for chemotherapy:

    Evidence of progressive marrow failure as manifested by the development of or worsening anemia (hemoglobin d 11 g/dL) and/or thrombocytopenia (platelet count d 100,000/mm³)
    Symptomatic or progressive lymphadenopathy, splenomegaly or hepatomegaly
    Has e 1 of the following disease-related symptoms:

    Weight loss > 10% within the past 6 months
    Extreme fatigue attributed to CLL
    Fevers > 100.5^oF for 2 weeks without evidence of infection
    Night sweats without evidence of infection
    Progressive lymphocytosis (not due to the effects of corticosteroids) with an increase of > 50% over a 2-month period or an anticipated doubling time of < 6 months NOTE: **Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease are not sufficient indications for study treatment
    PATIENT CHARACTERISTICS:

    ECOG performance status 0-3
    Life expectancy e 12 months
    Total bilirubin d 3.0 times upper limit of normal (ULN) (unless due to Gilbert's disease)

    Direct bilirubin < 1.5 mg/dL (in patients with Gilbert's disease)
    SGOT d 3.0 times ULN (unless due to hepatic involvement by CLL)
    Creatinine d 1.5 times ULN
    Urine protein:creatinine ratio < 1.0 OR < 1 g of protein by 24-hour urine collection
    Not pregnant or nursing
    Negative pregnancy test
    Fertile patients must use effective contraception during and for 12 months after completion of study treatment
    Willing to provide mandatory blood and tissue samples
    None of the following cardiovascular conditions:

    NYHA class III-IV heart disease
    Myocardial infarction within the past 6 months
    Unstable angina
    Stroke, cerebrovascular accident, or transient ischemic attack within the past 6 months
    Arterial thromboembolic events within the past 12 months
    Clinically significant peripheral vascular disease
    Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 100 mm Hg

    Hypertension allowed provided it is controlled with a stable anti-hypertensive regimen
    History of hypertensive crises or hypertensive encephalopathy
    Deep venous thromboses or pulmonary embolism within the past 12 months
    No evidence of bleeding diathesis or coagulopathy
    No uncontrolled or active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment
    No active or recent history (within the past 30 days) of hemoptysis (e ½ teaspoon of bright red blood per episode)
    No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
    No active peptic ulcer disease
    No serious non-healing wound, ulcer, or bone fracture
    No significant traumatic injury within the past 28 days
    No uncontrolled infection
    No active HIV infection
    No other active primary malignancy (except nonmelanoma skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting survival to d 2 years
    No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude study participation
    PRIOR CONCURRENT THERAPY:

    Prior corticosteroids allowed
    More than 4 weeks since prior radiotherapy
    More than 28 days since prior and no

  • Consent Forms: RC0783 Consent
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