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

Primary Purpose

Leukemia, Myeloid, Acute

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Chidamide
Sponsored by
Sichuan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Acute

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • West China Hospital of Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chidamide

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

100 day adverse events (AE)
non-hematologic adverse events
Non-relapse mortality (NRM)
Non-relapse mortality of this group of patients at the end of 6 month
Overall survival (OS)
Overall survival of this group of patients at the end of 2 year
Relapse rate
Relapse rate of this group of patients at the end of 2 year
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
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

Full Information

First Posted
December 27, 2022
Last Updated
December 27, 2022
Sponsor
Sichuan University
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1. Study Identification

Unique Protocol Identification Number
NCT05682755
Brief Title
Chidamide Prevents Recurrence of High-risk AML After Allo-HSCT
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chidamide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Chidamide
Intervention Description
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 Measure Information:
Title
Progression free survival (PFS)
Description
Progression free survival of this group of patients at the end of 2 year
Time Frame
2 years
Secondary Outcome Measure Information:
Title
100 day adverse events (AE)
Description
non-hematologic adverse events
Time Frame
Day +100
Title
Non-relapse mortality (NRM)
Description
Non-relapse mortality of this group of patients at the end of 6 month
Time Frame
6 months
Title
Overall survival (OS)
Description
Overall survival of this group of patients at the end of 2 year
Time Frame
2 years
Title
Relapse rate
Description
Relapse rate of this group of patients at the end of 2 year
Time Frame
2 years
Title
Cumulative incidence of acute graft versus host disease (aGVHD)
Description
Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100
Time Frame
Day +100
Title
Cumulative incidence of chronic graft versus host disease (cGVHD)
Description
Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Ji, MD
Phone
86-28-85422370
Email
jieji@scu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Release after the publication of results of this trial
IPD Sharing Time Frame
after the publication of results of this trial

Learn more about this trial

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

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