Back to resultsA Study of Chidamide With AZA in MRD Positive AML After Transplant
Primary Purpose
AML, Adult, Minimal Residual Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
chidamide and azacitidine
Sponsored by
About this trial
This is an interventional treatment trial for AML, Adult
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with AML (diagnostic criteria refer to WHO2016 criteria, except M3) can detect small residual lesions (MRD) positive after allogeneic hematopoietic stem cell transplantation (allo-HSCT); ≥18 years old; ECOG≤3; lifespan≥3 months; Take contraceptive measures; Sign informed consent. Exclusion Criteria: Allergic to the study drug; A gastrointestinal condition that prevents oral medication; active infection; Dysfunction of vital organs; other malignancies; HIV infection; HBV or HCV; The QT interval is prolonged; Pregnant or lactating women; Is participating in other clinical studies; The researchers did not consider it appropriate to participate in this study.
Sites / Locations
- Guangdong Provincial People's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
chidamide and azacitidine
Arm Description
Outcomes
Primary Outcome Measures
the rate of RFS in 6 months
relapse-free survival
Secondary Outcome Measures
the rate of MRD turn negative in 6 months
minimal residual disease turn negative
the time length of MRD negative
minimal residual disease negative
the 1 year/2 year RFS
relapse-free survival
the 1 year/2 year OS
overall survival
the rate of GVHD
graft-versus-host disease
Incidence of Treatment-Emergent Adverse Events
Grade 1 to Grade 4 ,according to Common Terminology Criteria for Adverse Events, versions 5.0
Full Information
NCT ID
NCT06066905
First Posted
September 19, 2023
Last Updated
September 27, 2023
Sponsor
Guangdong Provincial People's Hospital
Collaborators
Shenzhen Chipscreen Biosciences Co.Ltd
1. Study Identification
Unique Protocol Identification Number
NCT06066905
Brief Title
A Study of Chidamide With AZA in MRD Positive AML After Transplant
Official Title
A Study of Chidamide With AZA in MRD Positive AML After Transplant
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital
Collaborators
Shenzhen Chipscreen Biosciences Co.Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
acute myeloid leukemia (AML) is a malignant tumor of the hematopoietic system with high heterogeneity in cytogenetics and molecular biology.Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is still the primary treatment option for patients with AML and the most effective method for radical treatment of AML.Despite considerable progress in allo-HSCT over the past decade, 30%-40% of patients still relapse, and post-transplant relapse remains the leading cause of death in patients with AML.
Detailed Description
Investigators proposed Chidamide combined with azacitidine as the prospective treatment for MRD-positive AML patients before and after transplantation, hoping to reduce the recurrence rate of transplantation and improve the transplantation effect. The efficacy and safety of the method will be verified by this clinical study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AML, Adult, Minimal Residual Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chidamide and azacitidine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
chidamide and azacitidine
Intervention Description
chidamide：10mg orally,day 1 to day 6 every week, Take it for two weeks, rest for two weeks,so 28 days for a circle, 12 circles totally.
azacitidine:50mg,subcutaneous injection,day 1 to day 5 every week, 28 days for a circle, 6 circles totally.
Primary Outcome Measure Information:
Title
the rate of RFS in 6 months
Description
relapse-free survival
Time Frame
6 months
Secondary Outcome Measure Information:
Title
the rate of MRD turn negative in 6 months
Description
minimal residual disease turn negative
Time Frame
6 months
Title
the time length of MRD negative
Description
minimal residual disease negative
Time Frame
24 months
Title
the 1 year/2 year RFS
Description
relapse-free survival
Time Frame
24 months
Title
the 1 year/2 year OS
Description
overall survival
Time Frame
24 months
Title
the rate of GVHD
Description
graft-versus-host disease
Time Frame
24 months
Title
Incidence of Treatment-Emergent Adverse Events
Description
Grade 1 to Grade 4 ,according to Common Terminology Criteria for Adverse Events, versions 5.0
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
T cell receptor excision circles (TRECs) level before and after treatment
Description
T cell receptor excision circles (TRECs) are released upon rearrangement of the T cell receptor.
Time Frame
24 months
Title
the rate of MRD turn negative in molecular genetic abnormality subtype
Description
minimal residual disease
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with AML (diagnostic criteria refer to WHO2016 criteria, except M3) can detect small residual lesions (MRD) positive after allogeneic hematopoietic stem cell transplantation (allo-HSCT);
≥18 years old;
ECOG≤3;
lifespan≥3 months;
Take contraceptive measures;
Sign informed consent.
Exclusion Criteria:
Allergic to the study drug;
A gastrointestinal condition that prevents oral medication;
active infection;
Dysfunction of vital organs;
other malignancies;
HIV infection;
HBV or HCV;
The QT interval is prolonged;
Pregnant or lactating women;
Is participating in other clinical studies;
The researchers did not consider it appropriate to participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
WENG jian yu, M.D.
Phone
020-83827812
Email
wengjianyu1969@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ling Wei, M.D.
Phone
020-83827812
Email
nick97@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WENG jian yu, M.D.
Organizational Affiliation
Department of Hematology, Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WENG jian yu, M.D.
Phone
（020）83827812
Email
wsswjy@sina.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Chidamide With AZA in MRD Positive AML After Transplant
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