Status:
COMPLETED
Daunorubicin Hydrochloride, Cytarabine and Oblimersen Sodium in Treating Patients With Previously Untreated Acute Myeloid Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
This randomized phase III trial is studying daunorubicin, cytarabine, and oblimersen to see how well they work compared to daunorubicin and cytarabine in treating older patients with previously untrea...
Detailed Description
OBJECTIVES: Primary I. Compare outcome, in terms of overall survival, disease-free survival, event-free survival, and complete response rate, in older patients with previously untreated acute myeloid...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- DISEASE CHARACTERISTICS:
- Histologically confirmed acute myeloid leukemia
- No promyelocytic leukemia
- History of antecedent myelodysplasia allowed provided that the patient received no prior cytotoxic therapy for myelodysplastic syndromes
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Prior growth factor and/or cytokine support allowed
- No concurrent routine or prophylactic myeloid growth factors
- Chemotherapy
- No prior chemotherapy for leukemia or myelodysplasia except under the following conditions:
- Emergency leukapheresis
- Emergency treatment for hyperleukocytosis with hydroxyurea
- No other concurrent chemotherapy
- Endocrine therapy
- No concurrent hormones except steroids for adrenal failure or hormones for non-disease-related conditions allowed (e.g., insulin for diabetes)
- Radiotherapy
- Prior cranial radiotherapy for CNS leukostasis (1 dose only) allowed
- No concurrent palliative radiotherapy
- Surgery
- Not specified
- Other
- Concurrent enrollment on CALGB-8461, CALGB-9665, and CALGB-9760 allowed
- No other concurrent investigational or commercial agents or therapies intended to treat the malignancy
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00085124
Start Date
December 1 2003
Last Update
May 30 2024
Active Locations (2)
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1
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
2
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210