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

Study Overview
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Brief Summary
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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.

Official Title
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The Efficacy and Safety of Azacytidine Combined With HAG Regimen Versus Azacytidine for Elderly Patients With Newly Diagnosed Myeloid Malignancy: a Prospective, Randomized Controlled Trial

Conditions
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Acute Myeloid Leukaemia; Myelodysplastic Syndromes;Chronic Myelomonocytic Leukemia

Intervention / Treatment
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* Drug: Azacytidine, HAG Regimen
* Drug: Azacytidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azacytidine + HAG Regimen<br>Azacytidine（75mg/m2 ）+ HAG Regimen（Homoharringtonine(HHT) 1mg/(m2.d) , Cytarabine 10mg/(m2.d), G-CSF 200ug/(m2.d) ) | Drug: Azacytidine, HAG Regimen<br>* Azacytidine（75mg/m2 QD for 7 days）+ HAG Regimen（Homoharringtonine(HHT) 1mg/(m2.d) for 14 days), Cytarabine 10mg/(m2.d) for 14 days, granulocyte colony-stimulating factor(G-CSF) 200ug/(m2.d) for 14 days until absolute neutrophil count(ANC) ≥ 10X109／L)<br>* Other names: Azacytidine, HAG Regimen (HHT Cytarabine G-CSF);|
| Active Comparator: Azacytidine<br>75mg/m2 | Drug: Azacytidine<br>* Azacytidine 75mg/m2 QD for 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants (Responders) Achieving Overall Response Rate(ORR) After the Fourth Cycle Treatments. |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Azacytidine; HAG regimen