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

Primary Purpose

Acute Myeloid Leukaemia; Myelodysplastic Syndromes;Chronic Myelomonocytic Leukemia

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Azacytidine, HAG Regimen
Azacytidine
Sponsored by
Shenzhen Second People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukaemia; Myelodysplastic Syndromes;Chronic Myelomonocytic Leukemia focused on measuring Azacytidine; HAG regimen

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shenzhen Second People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Azacytidine + HAG Regimen

Azacytidine

Arm Description

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

75mg/m2

Outcomes

Primary Outcome Measures

Number of Participants (Responders) Achieving Overall Response Rate(ORR) After the Fourth Cycle Treatments.

Secondary Outcome Measures

Full Information

First Posted
March 8, 2019
Last Updated
March 14, 2022
Sponsor
Shenzhen Second People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03873311
Brief Title
Azacytidine + HAG Regimen vs. Azacytidine for Elderly Patients With Newly Diagnosed Myeloid Malignancy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Second People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukaemia; Myelodysplastic Syndromes;Chronic Myelomonocytic Leukemia
Keywords
Azacytidine; HAG regimen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Azacytidine + HAG Regimen
Arm Type
Experimental
Arm Description
Azacytidine（75mg/m2 ）+ HAG Regimen（Homoharringtonine(HHT) 1mg/(m2.d) , Cytarabine 10mg/(m2.d), G-CSF 200ug/(m2.d) )
Arm Title
Azacytidine
Arm Type
Active Comparator
Arm Description
75mg/m2
Intervention Type
Drug
Intervention Name(s)
Azacytidine, HAG Regimen
Other Intervention Name(s)
Azacytidine, HAG Regimen (HHT Cytarabine G-CSF)
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Azacytidine
Intervention Description
Azacytidine 75mg/m2 QD for 7 days.
Primary Outcome Measure Information:
Title
Number of Participants (Responders) Achieving Overall Response Rate(ORR) After the Fourth Cycle Treatments.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shenzhen Second People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Du, Phd
Phone
075583366388
Ext
8196
Email
duxingz@medmail.com.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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