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

Sponsor
Guangdong Provincial People's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06066905
Collaborator
Shenzhen Chipscreen Biosciences Co.Ltd (Other)
60
Enrollment
1
Location
1
Arm
38
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: chidamide and azacitidine
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study of Chidamide With AZA in MRD Positive AML After Transplant
Anticipated Study Start Date :
Sep 30, 2023
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: chidamide and azacitidine

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.

Outcome Measures

Primary Outcome Measures

  1. the rate of RFS in 6 months [6 months]

    relapse-free survival

Secondary Outcome Measures

  1. the rate of MRD turn negative in 6 months [6 months]

    minimal residual disease turn negative

  2. the time length of MRD negative [24 months]

    minimal residual disease negative

  3. the 1 year/2 year RFS [24 months]

    relapse-free survival

  4. the 1 year/2 year OS [24 months]

    overall survival

  5. the rate of GVHD [24 months]

    graft-versus-host disease

  6. Incidence of Treatment-Emergent Adverse Events [24 months]

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

Other Outcome Measures

  1. T cell receptor excision circles (TRECs) level before and after treatment [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 [24 months]

    minimal residual disease

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Guangdong Provincial People's Hospital Guangzhou Guangdong China

Sponsors and Collaborators

  • Guangdong Provincial People's Hospital
  • Shenzhen Chipscreen Biosciences Co.Ltd

Investigators

  • Principal Investigator: WENG jian yu, M.D., Department of Hematology, Guangdong Provincial People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
WENG Jian yu, professor, Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier:
NCT06066905
Other Study ID Numbers:
  • Chidaza101
First Posted:
Oct 4, 2023
Last Update Posted:
Oct 4, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasm, Residual
Azacitidine

Study Results

No Results Posted as of Oct 4, 2023