A prospective randomized comparison of high-dose cytarabine and high-dose daunorubicin in the induction chemotherapy for acute myeloid leukemia

Asan Medical Center0 个研究点目标入组 380 人开始时间: 待定最近更新: 2020年5月18日

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•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)

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