drugset / Trial / NCT03873311

Azacytidine + HAG Regimen vs. Azacytidine for Elderly Patients With Newly Diagnosed Myeloid Malignancy

NCT03873311

Phase 4 Unknown 114 enrolled Shenzhen Second People's Hospital
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

EvaluationDrugModalityDoseRoute
Comparator Azacitidine Other / unclassified 75 mg/m2
Subject Cytarabine Small molecule 10 mg/m2
Subject Homoharringtonine Small molecule 1 mg/m2

Indications