NCT03507842Enrolling by invitationPhase 3
A Prospective Randomized Comparison of HDAC Vs AD in the Induction Chemothrapy for AML.
A Prospective Randomized Comparison of High-dose Cytarabine an High-dose Daunorubicin in the Induction Chemothrapy for Acute Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 17 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 380 (estimated)
- First submitted
- 4 Apr 2018
- Start date
- 1 Mar 2018
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Asan Medical Center
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT03507842
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 380
- From 1 Mar 2018 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of uncontrolled and/or severe medical condition (infection, bleeding, cardiovascular disease including myocardial infarction within previous 6 months.)
Other illness
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 15 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asan Medical Center, University of Ulsan College of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.