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

Minimal Residual Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06066905
• Other study ID #: Chidaza101
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2023
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: Guangdong Provincial People's Hospital
• Contact: WENG jian yu, M.D.
• Phone: 020-83827812
• Email: wengjianyu1969[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• AML, Adult
• Minimal Residual Disease
• Neoplasm, Residual

Intervention

Drug:
• chidamide and azacitidine
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.

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital	Shenzhen Chipscreen Biosciences Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	T cell receptor excision circles (TRECs) level before and after treatment	T cell receptor excision circles (TRECs) are released upon rearrangement of the T cell receptor.	24 months
Other	the rate of MRD turn negative in molecular genetic abnormality subtype	minimal residual disease	24 months
Primary	the rate of RFS in 6 months	relapse-free survival	6 months
Secondary	the rate of MRD turn negative in 6 months	minimal residual disease turn negative	6 months
Secondary	the time length of MRD negative	minimal residual disease negative	24 months
Secondary	the 1 year/2 year RFS	relapse-free survival	24 months
Secondary	the 1 year/2 year OS	overall survival	24 months
Secondary	the rate of GVHD	graft-versus-host disease	24 months
Secondary	Incidence of Treatment-Emergent Adverse Events	Grade 1 to Grade 4 ,according to Common Terminology Criteria for Adverse Events, versions 5.0	24 months