A Study of Chidamide With AZA in MRD Positive AML After Transplant

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Enrolling

Conditions: AML, Adult; Minimal Residual Disease

Treatments: Drug: chidamide and azacitidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06066905

Chidaza101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

chidamide and azacitidine

Experimental group

Treatment:

Drug: chidamide and azacitidine