A prospective randomized comparison of high-dose cytarabine and high-dose daunorubicin in the induction chemotherapy for acute myeloid leukemia
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0004988
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 380
Previously-untreated AML (= 20% blasts in bone marrow and/or peripheral blood)
-Age of 15 years or older, 60 years or younger
-Adequate performance status (Karnofsky score of 50 or more)
-Adequate hepatic and renal function (AST, ALT, and bilirubin < 2.5 x upper normal limit and creatinine < 2.0 mg/dL & creatinine clearance = 50 mL/min). Elevation of AST or ALT due to hepatic infiltration of leukemic cells will be permitted.
-Adequate cardiac function (left ventricular ejection fraction =45% on heart scan or echocardiogram)
-Signed informed consent
-Patients with history of chemotherapy for leukemia or cytarabine and anthracycline treatment for any malignancy. Hydroxyurea for reduction of leukemic cell burden before induction chemotherapy will be permitted.
-Patients with acute promyelocytic leukemia or leukemia with BCR-ABL gene rearrangement
-Patients with blast crisis of chronic myeloid leukemia
-Patients with central nervous system (CNS) leukemia or granulocytic sarcoma without bone marrow involvement
-Presence of uncontrolled and/or severe medical condition (infection, bleeding, cardiovascular disease including myocardial infarction within previous 6 months.)
- Patients with major comorbidities or organ failure
-Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
-Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event Free Survival;Complete Remission;CR without minimal residual disease;CR with incomplete hematologic recovery (CRi);Morphologic leukemia-free state (MLFS);Cumulative incidence of relapse (reappearance of leukemic blasts in the peripheral blood or > 5% blasts in the bone marrow, not attributable to another cause [eg, bone marrow regeneration after consolidation therapy] or extramedullary relapse) after date of CR;Overall Survival
- Secondary Outcome Measures
Name Time Method Toxicity evaluation