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

Shenzhen University

Status and phase: Unknown; Phase 4

Conditions: Acute Myeloid Leukaemia; Myelodysplastic Syndromes;Chronic Myelomonocytic Leukemia

Treatments: Drug: Azacytidine, HAG Regimen; Drug: Azacytidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03873311

20190109

Details and patient eligibility

About

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.

Enrollment: 114 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Azacytidine + HAG Regimen

Experimental group

Description:

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

Treatment:

Drug: Azacytidine, HAG Regimen

Azacytidine

Active Comparator group

Description:

75mg/m2

Treatment:

Drug: Azacytidine