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

Not Applicable

Recruiting

• Conditions: Minimal Residual Disease; AML, Adult
• Interventions: Drug: chidamide and azacitidine

• Registration Number: NCT06066905
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Study Timeline

• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-09-27
• Status Verified: 2023-10
• Study First Posted: 2023-10-04
• Study Start: 2023-10-26
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-27
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chidamide and azacitidine	chidamide and azacitidine	-

Primary Outcome Measures

Name	Time	Method
the rate of RFS in 6 months	6 months	relapse-free survival

Secondary Outcome Measures

Name	Time	Method
the rate of MRD turn negative in 6 months	6 months	minimal residual disease turn negative
the time length of MRD negative	24 months	minimal residual disease negative
the 1 year/2 year RFS	24 months	relapse-free survival
the 1 year/2 year OS	24 months	overall survival
the rate of GVHD	24 months	graft-versus-host disease
Incidence of Treatment-Emergent Adverse Events	24 months	Grade 1 to Grade 4 ,according to Common Terminology Criteria for Adverse Events, versions 5.0

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China