Status:

RECRUITING

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

Lead Sponsor:

Guangdong Provincial People's Hospital

Collaborating Sponsors:

Shenzhen Chipscreen Biosciences Co.Ltd

Conditions:

AML, Adult

Minimal Residual Disease

Eligibility:

All Genders

18+ years

Phase:

NA

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-HSC...

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 transpla...

Eligibility Criteria

Inclusion

  • 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);
  • ≥18 years old;
  • ECOG≤3;
  • lifespan≥3 months;
  • Take contraceptive measures;
  • Sign informed consent.

Exclusion

  • Allergic to the study drug;
  • A gastrointestinal condition that prevents oral medication;
  • active infection;
  • Dysfunction of vital organs;
  • other malignancies;
  • HIV infection;
  • HBV or HCV;
  • The QT interval is prolonged;
  • Pregnant or lactating women;
  • Is participating in other clinical studies;
  • The researchers did not consider it appropriate to participate in this study.

Key Trial Info

Start Date :

October 26 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06066905

Start Date

October 26 2023

End Date

December 1 2026

Last Update

October 27 2023

Active Locations (1)

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Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China