Clinical trial NCT06066905: 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
Overall status: RECRUITING
Phase: NA
Conditions: AML, Adult
Minimal Residual Disease
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Shenzhen Chipscreen Biosciences Co.Ltd
First posted: 2023-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: the rate of RFS in 6 months
timeFrame: 6 months
Secondary outcomes:
measure: the rate of MRD turn negative in 6 months
timeFrame: 6 months
measure: the time length of MRD negative
timeFrame: 24 months
measure: the 1 year/2 year RFS
timeFrame: 24 months
measure: the 1 year/2 year OS
timeFrame: 24 months
measure: the rate of GVHD
timeFrame: 24 months
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 24 months
Other outcomes:
measure: T cell receptor excision circles (TRECs) level before and after treatment
timeFrame: 24 months
measure: the rate of MRD turn negative in molecular genetic abnormality subtype
timeFrame: 24 months
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Department of Hematology, Guangdong Provincial People's Hospital
name: WENG jian yu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: