A Phase 3 interventional study of High dose Cytarabine and Cytarabine in Acute Myeloid Leukemia, sponsored by Asan Medical Center. Enrolling by invitation at 1 site in Korea, Republic of. Open to participants aged 15 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Asan Medical Center · Phase 3, Interventional, and Treatment
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).
Induction chemotherapy
Re-induction chemotherapy
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 380 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.
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Exclusion Criteria:
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).
Drug: High dose Cytarabine
cytarabine 200 mg/m2/day continuous iv infusion for 7 days (D1-7) plus high-dose daunorubicin 90 mg/m2/day continuous iv infusion for 3 days (D1-3).
Drug: Cytarabine · Drug: Hign dose Daunorubicin
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).
Also known as: HDAC
cytarabine 200 mg/m2/day continuous iv infusion for 7 days (D1-7)
Also known as: AD
Hign dose Daunorubicin 90 mg/m2/day continuous iv infusion for 3 days (D1-3).
Also known as: AD
Cumulative incidence of relapse
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
Time frame: 3 years
Event-free survival
Defined for all patients; measured from the starting date of registration to the date of induction treatment failure, or relapse from CR, or death from any cause; patients not known to have any of these events are censored on the date they were examined
Time frame: 3years
Overall survival
Defined for all patients; measured from the starting date of registration to the date of death from any cause-patients not known to have died at last follow-up are censored on the date they were last known to be alive
Time frame: 3years
Plan to share: No
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Asan Medical Center