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Recruiting NCT05682755

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

Phase I / Phase II Interventional Leukemia, Myeloid, Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chidamide.
Who it may be relevant to
Registry conditions: Leukemia, Myeloid, Acute. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Progression free survival (PFS) [Time frame: 2 years]
Secondary outcome measures (6)
  • 100 day adverse events (AE) [Time frame: Day +100]
  • Non-relapse mortality (NRM) [Time frame: 6 months]
  • Overall survival (OS) [Time frame: 2 years]
  • Relapse rate [Time frame: 2 years]
  • Cumulative incidence of acute graft versus host disease (aGVHD) [Time frame: Day +100]
  • Cumulative incidence of chronic graft versus host disease (cGVHD) [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF);
  • KPS score > 60 or ECOG score 0-2;
  • The expected survival period > 3 months;
  • Received allo-HSCT and achieved complete remission (CR);
  • Reach the standard of hematopoietic reconstitution (neutrophil count ≥ 0.5×10\^9/L for 3 consecutive days without G-CSF application, platelet count ≥ 20×10\^9/L for 7 consecutive days without platelet transfusion, Hb ≥ 80 g /L without red blood cell transfusion); and neutrophil count ≥ 1.5×10\^9/L, platelet count ≥ 50×10\^9/L within 45 days after transplantation;
  • No central nervous system involvement or clinical symptoms after transplantation;
  • Those who have no serious functional damage to important organs of the body;
  • Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;
  • 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

  • Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;
  • Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;
  • 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;
  • Poor graft function (PGF) occurred after allo-HSCT;
  • Combined with other malignant tumors and require treatment;
  • Active GVHD;
  • Have a history of allergy to Chidamide;
  • Pregnant or lactating females;
  • Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;
  • Patients with active chronic hepatitis B or active hepatitis C;
  • History of prolonged QT syndrome;
  • Patients considered by other researchers to be unsuitable for this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • West China Hospital of Sichuan University — Chengdu

Identifiers

NCT: NCT05682755 · PTChi 1.0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗