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Status:

COMPLETED

S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML

Lead Sponsor:

SWOG Cancer Research Network

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Leukemia

Eligibility:

All Genders

18-60 years

Phase:

PHASE3

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop cancer cells from dividing so they stop growing and die. Monoclonal antibodies, such as gemtu...

Detailed Description

OBJECTIVES: * Compare disease-free survival of patients with previously untreated de novo acute myeloid leukemia treated with induction therapy comprising cytarabine and daunorubicin with vs without ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspiration and biopsy\* within the past 14 days
  • No M3 disease NOTE: \*Patients with marked leukocytosis may be registered before the availability of biopsy results if the absolute blast count is ≥ 100,000 cells/µL
  • No blastic transformation of chronic myelogenous leukemia
  • No pre-existing hematologic disorder evolving to AML (e.g., myelodysplasia or secondary leukemia)
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 to 60
  • Performance status
  • Zubrod 0-3
  • Life expectancy
  • Not specified
  • Hematopoietic
  • See Disease Characteristics
  • Hepatic
  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN
  • No known hepatitis B or C infection
  • No known liver disease
  • Renal
  • Not specified
  • Cardiovascular
  • LVEF ≥ 50% by MUGA or echocardiogram
  • No unstable cardiac arrhythmias
  • No unstable angina
  • Other
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • No prior systemic chemotherapy
  • Prior hydroxyurea to control high cell counts allowed
  • No more than 1 prior dose of intrathecal chemotherapy for acute leukemia
  • Concurrent intrathecal chemotherapy allowed during induction therapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • Not specified
  • Surgery
  • Not specified

Exclusion

    Key Trial Info

    Start Date :

    July 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2014

    Estimated Enrollment :

    637 Patients enrolled

    Trial Details

    Trial ID

    NCT00085709

    Start Date

    July 1 2004

    End Date

    August 1 2014

    Last Update

    September 30 2015

    Active Locations (279)

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    Page 1 of 70 (279 locations)

    1

    Providence Cancer Center

    Anchorage, Alaska, United States, 99508

    2

    Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

    Fort Smith, Arkansas, United States, 72903

    3

    Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States, 72205

    4

    Alta Bates Summit Comprehensive Cancer Center

    Berkeley, California, United States, 94704