drugset / Trial / NCT03873311
Azacytidine + HAG Regimen vs. Azacytidine for Elderly Patients With Newly Diagnosed Myeloid Malignancy
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective is to explore the efficacy and safety of azacytidine and HAG regimen versus azacytidine for elderly patients with Newly Diagnosed MDS/AML/CMML in China. This is a post-marketing, interventional, multi-center, double-arm, prospective, open-label, randomized controlled study in elderly patients with MDS/AML/CMML in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given azacytidine + HAG regimen or azacytidine under the conditions of informed consent and frequent monitoring according to the clinical guideline.
Timeline
- Start
- 2019-09-01
- Primary completion
- 2022-12-01
- Completion
- 2023-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azacitidine | Other / unclassified | 75 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 10 mg/m2 | — |
| Subject | Homoharringtonine | Small molecule | 1 mg/m2 | — |