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Trial Title:
A Study of Chidamide With AZA in MRD Positive AML After Transplant
NCT ID:
NCT06066905
Condition:
AML, Adult
Minimal Residual Disease
Conditions: Official terms:
Neoplasm, Residual
Azacitidine
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
chidamide and azacitidine
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.
Arm group label:
chidamide and azacitidine
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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);
2. ≥18 years old;
3. ECOG≤3;
4. lifespan≥3 months;
5. Take contraceptive measures;
6. Sign informed consent.
Exclusion Criteria:
1. Allergic to the study drug;
2. A gastrointestinal condition that prevents oral medication;
3. active infection;
4. Dysfunction of vital organs;
5. other malignancies;
6. HIV infection;
7. HBV or HCV;
8. The QT interval is prolonged;
9. Pregnant or lactating women;
10. Is participating in other clinical studies;
11. The researchers did not consider it appropriate to participate in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
WENG jian yu, M.D.
Phone:
（020）83827812
Email:
wsswjy@sina.com
Start date:
October 26, 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
Shenzhen Chipscreen Biosciences Co.Ltd
Agency class:
Other
Source:
Guangdong Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06066905
