RecruitingPhase 1Phase 2NCT05682755

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


Sponsor

Sichuan University

Enrollment

77 participants

Start Date

Dec 22, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called chidamide (an epigenetic medication that affects how genes are expressed) can prevent acute myeloid leukemia (AML) from coming back in high-risk patients after they have received a stem cell transplant from a donor (allo-HSCT). **You may be eligible if...** - You are between 18 and 65 years old - You have high-risk AML and have undergone a successful donor stem cell transplant - You have achieved complete remission and your blood counts have recovered - You have no active graft-versus-host disease (GVHD) or central nervous system involvement - Your major organs are functioning well **You may NOT be eligible if...** - You have serious heart, liver, or kidney disease - You have active, uncontrolled infection - You have poor graft function after transplant - You have active GVHD - You have HIV, active hepatitis B or C, or a history of prolonged QT syndrome - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChidamide

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


Locations(1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

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NCT05682755


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