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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Leukemia, Myeloid, Acute
• Intervention / Treatment: Drug: Chidamide

• Study Type: Interventional
• Enrollment (Anticipated): 77
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610044
      • Recruiting
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 ≥ 0.5×10^9/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;
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS)	Progression free survival of this group of patients at the end of 2 year	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
100 day adverse events (AE)	non-hematologic adverse events	Day +100
Non-relapse mortality (NRM)	Non-relapse mortality of this group of patients at the end of 6 month	6 months
Overall survival (OS)	Overall survival of this group of patients at the end of 2 year	2 years
Relapse rate	Relapse rate of this group of patients at the end of 2 year	2 years
Cumulative incidence of acute graft versus host disease (aGVHD)	Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100	Day +100
Cumulative incidence of chronic graft versus host disease (cGVHD)	Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year	2 years

Collaborators and Investigators

• Sponsor: Sichuan University

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: December 27, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: December 27, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Recurrence
• Other Study ID Numbers: PTChi 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Release after the publication of results of this trial
• IPD Sharing Time Frame: after the publication of results of this trial
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No