Daunorubicin Hydrochloride, Cytarabine and Oblimersen Sodium in Treating Patients With Previously Untreated Acute Myeloid Leukemia

Completed · Phase 3

Conditions studied: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia

In brief

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 untreated acute myeloid leukemia. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of daunorubicin and cytarabine by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without oblimersen in treating acute myeloid leukemia.

Key facts

Study ID

NCT00085124

Run by

National Cancer Institute (NCI)

People needed

500

Starts

2003-12-01

Last updated by the study team

2026-06-01

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Cancer and Leukemia Group B — Chicago, Illinois, United States
• Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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