High dose Cytarabine: High dose Cytarabine 3.0 g/m2 q12hr 3-hour iv infusion on days 1, 3, 5 plus daunorubicin 45 mg/m2/day continuous iv infusion for 3 days (D1-3).
Cytarabine: cytarabine 200 mg/m2/day continuous iv infusion for 7 days (D1-7)
Hign dose Daunorubicin: Hign dose Daunorubicin 90 mg/m2/day continuous iv infusion for 3 days (D1-3).
Study summary
This trial is a single-center, non-blind, two-arm randomized prospective controlled trial to compare the effectiveness of two induction chemotherapy regimens (high-dose cytarabine plus daunorubicin \[HDAC\] vs. cytarabine plus high-dose daunorubicin \[AD\]) in acute myeloid leukemia (AML). The primary hypothesis of the study is that AD is superior to HDAC in terms of event-free survival (EFS, time from registration to induction failure, relapse, or death).
Eligibility
Sex
ALL
Min age
15 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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.)
* 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)
Primary outcome measure(s)
Cumulative incidence of relapse — 3 years defined for all patients achieving CR; measured from the date of CR achievement until the date of relapse; patients not known to have relapsed are censored on the date they were last examined; patients who died without relapse are counted as a competing cause of failure
Trial sites (1)
Facility
City
Region
Status
Asan Medical Center, University of Ulsan College of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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