NCT03507842

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

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 15 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Detailed description

* Induction chemotherapy * Arm I \[HDAC\]: 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). * Arm II \[AD\]: cytarabine 200 mg/m2/day continuous iv infusion for 7 days (D1-7) plus daunorubicin 90 mg/m2/day continuous iv infusion for 3 days (D1-3). * Interim bone marrow examination Interim bone marrow aspiration and biopsy will be done between 14 and 21 days after start of induction chemotherapy. If bone marrow has blasts \< 10%, no additional chemotherapy will be given until the recovery of blood counts (absolute neutrophil counts rise over 1,000/μL and platelet counts over 100,000/μL) or post-induction day 35, when bone marrow examination will be repeated to evaluate CR. After the marrow examination, re-induction course will be given. If interim bone marrow examination shows persistent leukemia (blasts ≥ 10%), re-induction course could be given. Patients who did not attain CR after the re-induction chemotherapy will be eliminated from the study. * Re-induction chemotherapy * Cytarabine 200 mg/m2/day iv infusion for 5 days (D1-5) plus daunorubicin 45 mg/m2/day iv infusion for 2 days (D1-2) Post-remission consolidation chemotherapy * Adverse risk group: up to 3 courses of intermediate-dose cytarabine (1.0 g/m2/day iv for 5 days \[D1-5\]) plus etoposide (150 mg/m2/day iv for 3 days \[D1-3\]) * Favorable/intermediate risk group: up to 3 courses of high-dose cytarabine (3.0 g/m2/day q12 hr iv for 3 days \[D1, 3, 5\]) * Autologous or allogeneic hematopoietic cell transplantation (HCT) can be performed based on the risk of relapse. * The bone marrow examination will be done after the completion of consolidation chemotherapy or before HCT.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	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).
DRUG	Cytarabine	cytarabine 200 mg/m2/day continuous iv infusion for 7 days (D1-7)
DRUG	Hign dose Daunorubicin	Hign dose Daunorubicin 90 mg/m2/day continuous iv infusion for 3 days (D1-3).

Timeline

• Start date: 2018-03-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2018-04-25
• Last updated: 2025-03-17

Locations

1 site across 1 country: South Korea