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Azacytidine + HAG Regimen in Elderly Patients With 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.
 
ClinicalTrials.gov Identifier: NCT03873311
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Shenzhen Second People's Hospital

Brief Summary:
The primary objective is to explore the effect of azacytidine + HAG regimen in objective response rate in elderly patients with MDS/AML/CMML in China. This is a post-marketing, interventional, single-center, single-arm, prospective, open-label 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 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 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical Efficacy of Azacytidine Combined With HAG Regimen in Elderly Patients With Myeloid Malignancy
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : June 1, 2022


Arm Intervention/treatment
Experimental: Azacytidine + HAG Regimen Drug: Azacytidine, HAG Regimen
HAG Regimen(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,Homoharringtonine(HHT) 1mg/(m2.d for 14 days)) +Azacytidine(75mg/m2 one time/week)




Primary Outcome Measures :
  1. Number of Participants (Responders) Achieving Objective Response Rate(ORR) [ Time Frame: From the start of study treatment (Day 1) to 8 months ]


Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • Age ≥ 60;
  • Patients who have undergoneMDS/AML/CMML;
  • Patients who don't take any drug including azacylate and HAG regiment;
  • 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
  • Pregnant women or lactating mothers
  • Patient or his/her family members disapprove of treatment or withdrawal from the treatment

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 ClinicalTrials.gov identifier (NCT number): NCT03873311


Locations
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China, Guangdong
Shenzhen Second People's Hospital Recruiting
Shenzhen, Guangdong, China, 518035
Contact: Xin Du, Phd    075583366388 ext 8196    duxingz@medmail.com.cn   
Sponsors and Collaborators
Shenzhen Second People's Hospital

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Responsible Party: Shenzhen Second People's Hospital
ClinicalTrials.gov Identifier: NCT03873311    
Other Study ID Numbers: 20190109
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
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
Leukemia
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Myelodysplastic-Myeloproliferative Diseases
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors