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Active Clinical Trials: Leukemia

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ProtocolTitle
SWOG-C10403
(Hematology- Acute Lymphocytic Leukemia (ALL))
An Intergroup Phase II Clinical Trial for Adolescents and Young Adults with Acute Lymphoblastic Leukemia (ALL) (1540)
  • Eligibility: click to view information

    DISEASE CHARACTERISTICS:

    Newly diagnosed acute lymphoblastic leukemia (ALL)

    B-precursor or T-precursor ALL

    No Burkitt type leukemia (FAB L3; SIg positive; t(8;14) or variant)

    No known Ph+ ALL at time of diagnosis

    Enrollment on CALGB-C10001 (or its successor trial) for CALGB patients with Philadelphia-positive ALL take priority over enrollment on this protocol

    Patients enrolled on this study but are later found to meet the following criteria for Ph+ ALL eligibility criteria for protocol CALGB-C10001 (or its successor trial) are removed from this study and enrolled on CALGB-C10001 (or its successor study):



    BCR-ABL fusion transcript determined by FISH or RT-PCR

    t(9;22)(q34;q11) or variant determined by cytogenetics

    All CALGB patients are required to participate in CALGB-8461

    All SWOG patients are required to participate in SWOG-9007

    PATIENT CHARACTERISTICS:



    ECOG performance status 0-2

    No Down syndrome

    PRIOR CONCURRENT THERAPY:



    No prior therapy for acute leukemia except emergency therapy (i.e., corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys

    Single-dose intrathecal cytarabine is allowed prior to registration for patient convenience provided systemic chemotherapy begins within 72 hours of intrathecal therapy

    Prior steroid therapy allowed



  • Consent Forms: C10403 Consent
SWOG-S0919
(Hematology- Acute Myelogenic Leukemia (AML))
A Phase II Study of Idarubicin and Ara-C in Combination with Pravastatin for Relapsed Acute Myelogenous Leukemia (1738)
  • Eligibility: click to view information

    DISEASE CHARACTERISTICS:

    Morphologically confirmed diagnosis of acute myeloid leukemia (AML)
    Must have received = 1 prior chemotherapy regimen for AML

    Any type of prior chemotherapy allowed
    Must have achieved a complete remission that lasted = 3 months after the last induction regimen and then subsequently relapsed

    Relapse must be documented by a bone marrow examination demonstrating > 5% blasts in the bone marrow not attributable to another cause
    No acute promyelocytic leukemia (i.e., APL, FAB M3) or blastic transformation of chronic myelogenous leukemia
    No clinical evidence of leptomeningeal disease
    Concurrent registration on research study SWOG-9007 required
    PATIENT CHARACTERISTICS:

    Zubrod performance status 0-2
    Serum creatinine = 2.0 times upper limit of normal (ULN)
    Total bilirubin = 2.0 times ULN (unless elevation is primarily due to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis AND not due to liver dysfunction)
    AST and ALT = 3.0 times ULN
    Ejection fraction = 45% by echocardiogram or MUGA scan
    Not pregnant or nursing
    Negative pregnancy test
    Fertile patients must use effective contraception
    No symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias
    No HIV positivity unless the following criteria are met:

    No history of AIDS-defining events
    CD4 count = 500/mm³
    Viral load < 25,000 copies (< 50 copies if on combination antiretroviral therapy)
    Not receiving zidovudine or stavudine as part of combination antiretroviral therapy
    No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as exhibiting ongoing signs/symptoms related to the infection with no improvement despite appropriate antibiotics or other treatment
    Other prior malignancy allowed provided patient is in remission from that malignancy
    PRIOR CONCURRENT THERAPY:

    See Disease Characteristics
    At least 6 months since prior chemotherapy or radiotherapy and recovered
    No prior autologous or allogeneic stem cell transplantation
    Prior or concurrent hydroxyurea to control high WBC counts allowed
    No concurrent statin treatments


  • Consent Forms: S0919 Consent
MCCRC-RC0783
(Hematology- Chronic Lymphocytic Leukemia (CLL))
Randomized 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
SWOG-9007
(Hematology- Leukemia Specimen Banking Studies)
Cytogenetic Studies in Leukemia Patients (1169)
  • Eligibility: click to view information

    **Study has lost funding. No CREDIT. No longer required for main study eligibility.**

    1. Pts. must be registered on one of the following SWOG treatment protocols: 8326, 8600, 8612, 9034, 9108 and all new leukemia protocols approved as of 1990.
    2. ECOG pts. must be registered to SWOG 9300.


  • HIPAA Forms: S9007 HIPAA
  • Consent Forms: S9007 NCI Consent
S9910
(Hematology- Leukemia Specimen Banking Studies)
Leukemia Centralized Reference Laboratories and Tissue Repositories, Ancillary (1168)
  • Eligibility: click to view information

    **Study has lost funding. No CREDIT. No longer required for main study eligibility.**
    1. Pts. must be registered on a SWOG treatment study for ALL, CLL, AML, or CML or MDS.

  • HIPAA Forms: S9910 HIPAA
  • Consent Forms: S9910 NCI Consent
EST-E2903
(Hematology-Chronic Lymphocytic Leukemia (CLL) 2nd Line)
Phase II Trial of Pentostatin, Cyclophosphamide and Rituximab (PCR) Followed By Campath-1H For Previously Treated Relapsed or Refractory Patients With Chronic Lymphocytic Leukemia (1180)
  • Eligibility: click to view information

    1. Must have a dx of B-CLL, meeting criteria listed in 3.1.1.1,3.1.1.2,3.1.1.3
    2. Pts. must require chemo, the last admin. of chemo. must have been completed 6 weeks or greater prior to study tx. Must meet indications for chemo. listed in section 3.1.2.1, 3.1.2.2,3.1.2.3, 3.1.2.4,3.1.2.5Pts.
    3. Pts. must have either: demonstrated progression after at least one cycle of either an alkylating agent-based or purine nucleoside based regimen, or failed to achieve a meaningful response, or relapsed after prior therapy.
    4. Prior therapy with Rituximab is OK, at least 8 weeks should have elapsed between the last Rituximab dose and reg.
    5. No previous PCR therapy or CAMPATH-1H therapy prior to entering study.
    6. No active infection requiring antibiotic.
    7. Pts. whose bone marrow function is attributable to dysplasia related to prior therapy are not eligible.
    8. Pts. must be tested for Hep B virus infection.

  • HIPAA Forms: E2903 HIPAA
  • Consent Forms: E2903 Consent
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