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

NCT05682755 | Recruiting Phase 1

• 1 other identifier: PTChi 1.0
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia, Myeloid, Acute

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

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

  2 years

Secondary Outcomes (6)

• 100 day adverse events (AE)

  Day +100

• Non-relapse mortality (NRM)

  6 months

• Overall survival (OS)

  2 years

• Relapse rate

  2 years

• Cumulative incidence of acute graft versus host disease (aGVHD)

  Day +100

Study Arms (1)

Chidamide

EXPERIMENTAL

Drug: Chidamide

Interventions

Chidamide DRUG

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

Chidamide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

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

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 12, 2023
• Study Start: December 22, 2022
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 12, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after the publication of results of this trial

Locations

CN (1)