Chidamide Prevents Recurrence of High-risk AML After Allo-HSCT

Sponsor
Sichuan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05682755
Collaborator
(none)
77
1
1
48.3
1.6

Study Details

Study Description

Brief Summary

The goal of this phase I/II clinical trial is to test in high-risk acute myeloid leukemia (AML) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:

• The efficacy and safety of chidamide maintenance therapy in reducing the recurrence rate and GVHD incidence in high-risk AML patients after allo-HSCT.

Participants will take oral chidamide (Epidaza) until 180 days after allo-HSCT.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
77 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Chidamide Prevents the Recurrence of High-risk Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem-cell Transplantation: A Prospective, Single-centered, Single-arm, Phase I/II Clinical Study
Actual Study Start Date :
Dec 22, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chidamide

Drug: Chidamide
initial time:platelet count ≥50×10^9/L after allo-HSCT initial dose: 5 mg oral twice weekly initial adjustment: according to the platelet count tested weekly platelet count ≥50×10^9/L-increased by 5 mg 20×10^9/L≤ platelet count <50×10^9/L-remains unchanged platelet count <50×10^9/L- reduced by 5 mg maximum dose: 20 mg oral twice weekly terminal time: 180 days after allo-HSCT

Outcome Measures

Primary Outcome Measures

  1. Progression free survival (PFS) [2 years]

    Progression free survival of this group of patients at the end of 2 year

Secondary Outcome Measures

  1. 100 day adverse events (AE) [Day +100]

    non-hematologic adverse events

  2. Non-relapse mortality (NRM) [6 months]

    Non-relapse mortality of this group of patients at the end of 6 month

  3. Overall survival (OS) [2 years]

    Overall survival of this group of patients at the end of 2 year

  4. Relapse rate [2 years]

    Relapse rate of this group of patients at the end of 2 year

  5. Cumulative incidence of acute graft versus host disease (aGVHD) [Day +100]

    Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100

  6. Cumulative incidence of chronic graft versus host disease (cGVHD) [2 years]

    Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF);

  2. KPS score > 60 or ECOG score 0-2;

  3. The expected survival period > 3 months;

  4. Received allo-HSCT and achieved complete remission (CR);

  5. Reach the standard of hematopoietic reconstitution (neutrophil count ≥ 0.5×109/L for 3 consecutive days without G-CSF application, platelet count ≥ 20×109/L for 7 consecutive days without platelet transfusion, Hb ≥ 80 g /L without red blood cell transfusion); and neutrophil count ≥ 1.5×109/L, platelet count ≥ 50×109/L within 45 days after transplantation;

  6. No central nervous system involvement or clinical symptoms after transplantation;

  7. Those who have no serious functional damage to important organs of the body;

  8. Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;

  9. Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose.

Exclusion Criteria:
  1. Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;

  2. Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;

  3. Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;

  4. Poor graft function (PGF) occurred after allo-HSCT;

  5. Combined with other malignant tumors and require treatment;

  6. Active GVHD;

  7. Have a history of allergy to Chidamide;

  8. Pregnant or lactating females;

  9. Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;

  10. Patients with active chronic hepatitis B or active hepatitis C;

  11. History of prolonged QT syndrome;

  12. Patients considered by other researchers to be unsuitable for this study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 West China Hospital of Sichuan University Chengdu Sichuan China 610044

Sponsors and Collaborators

  • Sichuan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jie Ji, Principle Investigator, Sichuan University
ClinicalTrials.gov Identifier:
NCT05682755
Other Study ID Numbers:
  • PTChi 1.0
First Posted:
Jan 12, 2023
Last Update Posted:
Jan 12, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2023