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

Phase 4

• Conditions: Acute Myeloid Leukaemia; Myelodysplastic Syndromes;Chronic Myelomonocytic Leukemia
• Interventions: Drug: Azacytidine, HAG Regimen; Drug: Azacytidine

• Registration Number: NCT03873311
• Lead Sponsor: Shenzhen Second People's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-13
• Study Start: 2019-09-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15
• Primary Completion: 2022-12-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Age ≥ 60;
• Patients with newly diagnoised diseases including MDS/AML/CMML;
• The ECOG behavior status score is less than 3 points;
• Agree to sign informed consent

Exclusion Criteria

• Patients with a history of sever heart disease;
• Patients with severe organ dysfunction;
• Patients with other malignancies
• Patients who are allergic to the treatment of drug ingredients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azacytidine + HAG Regimen	Azacytidine, HAG Regimen	Azacytidine（75mg/m2 ）+ HAG Regimen（Homoharringtonine(HHT) 1mg/(m2.d) , Cytarabine 10mg/(m2.d), G-CSF 200ug/(m2.d) )
Azacytidine	Azacytidine	75mg/m2

Primary Outcome Measures

Name	Time	Method
Number of Participants (Responders) Achieving Overall Response Rate(ORR) After the Fourth Cycle Treatments.	4 months

Trial Locations

Locations (1)

Shenzhen Second People's Hospital; 🇨🇳 Shenzhen, Guangdong, China