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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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