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

Sponsor
Shenzhen Second People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03873311
Collaborator
(none)
114
Enrollment
1
Location
2
Arms
45
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
114 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Azacytidine + HAG Regimen

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

Drug: Azacytidine, HAG Regimen
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)
Other Names:
  • Azacytidine, HAG Regimen (HHT Cytarabine G-CSF)

    		•
    Active Comparator: Azacytidine

    75mg/m2

    Drug: Azacytidine
    Azacytidine 75mg/m2 QD for 7 days.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants (Responders) Achieving Overall Response Rate(ORR) After the Fourth Cycle Treatments. [4 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shenzhen Second People's Hospital Shenzhen Guangdong China 518035

    Sponsors and Collaborators

    • Shenzhen Second People's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shenzhen Second People's Hospital
    ClinicalTrials.gov Identifier:
    NCT03873311
    Other Study ID Numbers:
    • 20190109
    First Posted:
    Mar 13, 2019
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shenzhen Second People's Hospital
    Azacytidine; HAG regimen
    Additional relevant MeSH terms:
    Leukemia, Myelomonocytic, Chronic
    Leukemia, Myelomonocytic, Juvenile
    Myelodysplastic Syndromes
    Cytarabine
    Azacitidine

    Study Results

    No Results Posted as of Mar 15, 2022