Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia
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)
About this trial
This is an interventional treatment trial for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Eligibility Criteria
Inclusion Criteria: 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 No concurrent hormonal therapy except hormones for non-disease-related conditions (e.g., insulin for diabetes, tamoxifen or equivalent for breast cancer prevention or adjuvant treatment, or estrogens or progestins for gynecologic indications) No prior radiotherapy for primary AML except cranial radiotherapy for CNS leukostasis No concurrent palliative radiotherapy No concurrent whole brain radiotherapy No other concurrent investigational or commercial agents or therapies No concurrent cyclooxygenase-2 inhibitors
Sites / Locations
- Ohio State University Medical Center
Arms of the Study
Arm 1
Experimental
Arm I
INDUCTION THERAPY: Patients receive oblimersen (G3139) IV continuously on days 1-10 and cytarabine IV continuously on days 4-10. Patients also receive daunorubicin IV daily on days 4-6. Patients with bone marrow cellularity of at least 20% and at least 5% leukemic blasts at day 17 or evidence of refractory disease receive a second induction comprising G3139 IV continuously on days 1-8, cytarabine IV continuously on days 4-8, and daunorubicin IV on days 4-5. CONSOLIDATION THERAPY: Beginning no sooner than 14 days after hematologic recovery from induction therapy, patients receive G3139 IV continuously on days 1-8 and cytarabine IV over 4 hours on days 4-8. Patients receive a second course of consolidation therapy no sooner than 14 days after hematologic recovery from the first course.