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NCT Number: NCT06066905

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

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.

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Key information

Conditions

AML, Adult Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Minimal Residual Disease Neoplasm, Residual Neoplasms Neoplasms by Histologic Type Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

WENG jian yu, M.D.

CONTACT

[email protected]

（020）83827812

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

chidamide and azacitidine

Drug

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.

Primary outcomes

  1. the rate of RFS in 6 months

    Time frame: 6 months

    relapse-free survival

Secondary outcomes

  1. the rate of MRD turn negative in 6 months

    Time frame: 6 months

    minimal residual disease turn negative

  2. the time length of MRD negative

    Time frame: 24 months

    minimal residual disease negative

  3. the 1 year/2 year RFS

    Time frame: 24 months

    relapse-free survival

  4. the 1 year/2 year OS

    Time frame: 24 months

    overall survival

  5. the rate of GVHD

    Time frame: 24 months

    graft-versus-host disease

  6. Incidence of Treatment-Emergent Adverse Events

    Time frame: 24 months

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

Other outcomes

  1. T cell receptor excision circles (TRECs) level before and after treatment

    Time frame: 24 months

    T cell receptor excision circles (TRECs) are released upon rearrangement of the T cell receptor.

  2. the rate of MRD turn negative in molecular genetic abnormality subtype

    Time frame: 24 months

    minimal residual disease

Study contacts

Contact information is provided by the study sponsor or research team.

Ling Wei, M.D.

CONTACT

[email protected]

020-83827812

WENG jian yu, M.D.

CONTACT

[email protected]

020-83827812

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Collaborators

  • Chipscreen Biosciences, Ltd.

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 4, 2023
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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