drugset / Trial / NCT03021330
Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML
Phase 3
Active not recruiting
1100 enrolled
Institute of Hematology & Blood Diseases Hospital, China
RandomizedParallel-groupOpen-labelTreatment
Summary
In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine. In the control arm, patients receive DA regimen with standard dose of cytarabine.The efficacy of induction therapy containing intermediate dose of cytarabine is evaluated and adverse events associated with treatment are recorded.The primary end point is overall survival.
Timeline
- Start
- 2017-02-08
- Primary completion
- 2026-05-15
- Completion
- 2027-10-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cytarabine | Small molecule | 100 mg/m2 | — |
| Comparator | Cytarabine | Small molecule | 1 g | — |
| Comparator | Daunorubicin | Small molecule | 60 mg/m2 | — |