- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03873311
Azacytidine + HAG Regimen vs. Azacytidine for Elderly Patients With Newly Diagnosed Myeloid Malignancy
March 14, 2022 updated by: Shenzhen Second People's Hospital
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
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
114
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Shenzhen, Guangdong, China, 518035
- Recruiting
- Shenzhen Second People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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)
)
|
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:
|
Active Comparator: Azacytidine
75mg/m2
|
Azacytidine 75mg/m2 QD for 7 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants (Responders) Achieving Overall Response Rate(ORR) After the Fourth Cycle Treatments.
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2019
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
March 8, 2019
First Submitted That Met QC Criteria
March 12, 2019
First Posted (Actual)
March 13, 2019
Study Record Updates
Last Update Posted (Actual)
March 15, 2022
Last Update Submitted That Met QC Criteria
March 14, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Bone Marrow Diseases
- Hematologic Diseases
- Myelodysplastic-Myeloproliferative Diseases
- Leukemia
- Leukemia, Myeloid
- Myelodysplastic Syndromes
- Leukemia, Myelomonocytic, Chronic
- Leukemia, Myelomonocytic, Juvenile
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Azacitidine
- Cytarabine
Other Study ID Numbers
- 20190109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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