Compares two chemotherapy combinations for acute myeloid leukemia
Compares two chemotherapy combinations as first treatment for acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: A Prospective Randomized Comparison of HDAC Vs AD in the Induction Chemothrapy for AML.
Key facts
- Where
- Seoul, South KoreaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 15 and 60 years old?
Source: NCT03507842, who can take part
Where in South Korea
- Asan Medical Center, University of Ulsan College of MedicineSeoul, South KoreaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Asan Medical Center
- Trial code
- NCT03507842
- Record updated
- 17 March 2025
- Original description
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).Read full original descriptionShow less
A Prospective Randomized Comparison of High-dose Cytarabine an High-dose Daunorubicin in the Induction Chemothrapy for Acute Myeloid Leukemia
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).
Inclusion: 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: Presence of uncontrolled and/or severe medical condition (infection, bleeding, cardiovascular disease including myocardial infarction within previous 6 months.); 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 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); 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; Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception.