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出境医 / 临床实验 / Azacytidine + HAG Regimen vs. Azacytidine for Elderly Patients With Newly Diagnosed Myeloid Malignancy

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

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
Acute Myeloid Leukaemia; Myelodysplastic Syndromes;Chronic Myelomonocytic Leukemia Drug: Azacytidine, HAG Regimen Drug: Azacytidine Phase 4

Study Design
Layout table for study information
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
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 Name: 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. [ Time Frame: 4 months ]

Eligibility Criteria
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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 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
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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
Tracking Information
First Submitted Date  ICMJE March 8, 2019
First Posted Date  ICMJE March 13, 2019
Last Update Posted Date July 29, 2020
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2020) 		Number of Participants (Responders) Achieving Overall Response Rate(ORR) After the Fourth Cycle Treatments. [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019) 		Number of Participants (Responders) Achieving Objective Response Rate(ORR) [ Time Frame: From the start of study treatment (Day 1) to 8 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Azacytidine + HAG Regimen vs. Azacytidine for Elderly Patients With Newly Diagnosed Myeloid Malignancy
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukaemia; Myelodysplastic Syndromes;Chronic Myelomonocytic Leukemia
Intervention  ICMJE
  • 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)
  • Drug: Azacytidine
    Azacytidine 75mg/m2 QD for 7 days.
Study Arms  ICMJE
  • Experimental: Azacytidine + HAG Regimen
    Azacytidine（75mg/m2 ）+ HAG Regimen（Homoharringtonine(HHT) 1mg/(m2.d) , Cytarabine 10mg/(m2.d), G-CSF 200ug/(m2.d) )
    Intervention: Drug: Azacytidine, HAG Regimen
  • Active Comparator: Azacytidine
    75mg/m2
    Intervention: Drug: Azacytidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2020) 		114
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2019) 		120
Estimated Study Completion Date  ICMJE June 1, 2023
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03873311
Other Study ID Numbers  ICMJE 20190109
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shenzhen Second People's Hospital
Study Sponsor  ICMJE Shenzhen Second People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shenzhen Second People's Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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