NCT06066905

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Oct 2023Dec 2026

First Submitted

Initial submission to the registry

September 19, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

October 26, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

3.1 years

First QC Date

September 19, 2023

Last Update Submit

October 26, 2023

Conditions

AML, AdultMinimal Residual Disease

Outcome Measures

Primary Outcomes (1)

  • the rate of RFS in 6 months

    relapse-free survival

    6 months

Secondary Outcomes (6)

  • the rate of MRD turn negative in 6 months

    6 months

  • the time length of MRD negative

    24 months

  • the 1 year/2 year RFS

    24 months

  • the 1 year/2 year OS

    24 months

  • the rate of GVHD

    24 months

  • +1 more secondary outcomes

Other Outcomes (2)

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

    24 months

  • the rate of MRD turn negative in molecular genetic abnormality subtype

    24 months

Study Arms (1)

chidamide and azacitidine

EXPERIMENTAL
Drug: chidamide and azacitidine

Interventions

chidamide and azacitidineDRUG

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.

chidamide and azacitidine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteNeoplasm, Residual

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamideAzacitidine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • WENG jian yu, M.D.

    Department of Hematology, Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

WENG jian yu, M.D.

CONTACT

020-83827812wengjianyu1969@163.com

Ling Wei, M.D.

CONTACT

020-83827812nick97@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 19, 2023

First Posted

October 4, 2023

Study Start

October 26, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 27, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)