drugset / Trial / NCT04087967
Study of DAC Combined With HAAG Regimen in Newly Diagnosed Younger AML Patients
Phase 3
Unknown
162 enrolled
The First Affiliated Hospital of Soochow University
Changzhou No.2 People's Hospital · collabJingjiang People's Hospital · collabSecond Affiliated Hospital of Soochow University · collabThe First People's Hospital of Lianyungang · collabThe Second People's Hospital of Huai'an · collabThe Third People's Hospital of Kunshan · collabZhangjiagang First People's Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of DAC combined with HAAG regimen in the induction treatment of newly diagnosed AML patients younger than 60 years.
Timeline
- Start
- 2019-04-01
- Primary completion
- 2021-05-31
- Completion
- 2022-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aclarubicin | Small molecule | 10 mg | Intravenous |
| Subject | Cytarabine | Small molecule | 10 mg/m2 | Subcutaneous |
| Subject | Cytarabine | Small molecule | 100 mg/m2 | Subcutaneous |
| Subject | Decitabine | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Homoharringtonine | Small molecule | 1 mg | Intravenous |
| Comparator | Idarubicin | Small molecule | 12 mg/m2 | Intravenous |