Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia

Completed · Phase 1

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(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

Phase I trial to study the effectiveness of combining oblimersen with cytarabine and daunorubicin in treating older patients who have previously untreated acute myeloid leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may help cytarabine and daunorubicin kill more cancer cells by making them more sensitive to chemotherapy.

Key facts

Study ID

NCT00039117

Run by

National Cancer Institute (NCI)

People needed

32

Starts

2002-04-01

Last updated by the study team

2015-12-04

Who can join

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

You may qualify if…

• Histologically confirmed primary or secondary acute myeloid leukemia (AML)
• More than 20% bone marrow blasts
• Myelodysplastic syndromes (MDS) or a chronic myeloproliferative disorder antecedent to AML allowed
• Therapy-related AML allowed
• No acute promyelocytic leukemia
• At least 4 weeks
• Bilirubin no greater than 2 mg/dL
• ALT and AST no greater than 2 times upper limit of normal (unless directly attributable to AML)
• Creatinine no greater than 2.5 mg/dL
• Ejection fraction at least 50% by MUGA or echocardiogram
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• No allergy to any of the study medications
• No other uncontrolled concurrent illness
• No serious medical or psychiatric illness that would preclude giving informed consent
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No prior therapy for primary AML except emergency leukapheresis
• No prior anthracyclines
• No prior chemotherapy for primary AML except hydroxyurea for hyperleukocytosis
• At least 3 months since prior chemotherapy for MDS or chronic myeloproliferative disorders antecedent to AML
• No other concurrent chemotherapy
• No concurrent corticosteroids as anti-emetics
• No concurrent steroids except for adrenal failure or septic shock

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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