drugset / Trial / NCT03507842
A Prospective Randomized Comparison of HDAC Vs AD in the Induction Chemothrapy for AML.
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2018-03-01
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 3 g | Intravenous |
| Subject | Daunorubicin | Small molecule | 45 mg/m2 | Intravenous |
| Subject | Daunorubicin | Small molecule | 90 mg/m2 | Intravenous |