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

Guangdong Provincial People's Hospital60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

AML, Adult Minimal Residual Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

the rate of RFS in 6 months

relapse-free survival

Time frame: 6 months

Secondary Outcomes

the rate of MRD turn negative in 6 months

minimal residual disease turn negative

Time frame: 6 months

the time length of MRD negative

minimal residual disease negative

Time frame: 24 months

the 1 year/2 year RFS

relapse-free survival

Time frame: 24 months

the 1 year/2 year OS

overall survival

Time frame: 24 months

the rate of GVHD

graft-versus-host disease

Time frame: 24 months

Incidence of Treatment-Emergent Adverse Events

Grade 1 to Grade 4 ,according to Common Terminology Criteria for Adverse Events, versions 5.0

Time frame: 24 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts