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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03873311
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : July 29, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukaemia; Myelodysplastic Syndromes;Chronic Myelomonocytic Leukemia Drug: Azacytidine, HAG Regimen Drug: Azacytidine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 1, 2019
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : June 1, 2023

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 Name: Azacytidine, HAG Regimen (HHT Cytarabine G-CSF)

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

Primary Outcome Measures :
  1. Number of Participants (Responders) Achieving Overall Response Rate(ORR) After the Fourth Cycle Treatments. [ Time Frame: 4 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03873311

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China, Guangdong
Shenzhen Second People's Hospital Recruiting
Shenzhen, Guangdong, China, 518035
Contact: Xin Du, Phd    075583366388 ext 8196   
Sponsors and Collaborators
Shenzhen Second People's Hospital
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Responsible Party: Shenzhen Second People's Hospital Identifier: NCT03873311    
Other Study ID Numbers: 20190109
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Myelodysplastic-Myeloproliferative Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors