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

Recruiting now · Phase 1/Phase 2

Conditions studied: Leukemia, Myeloid, Acute

In brief

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.

Key facts

Study ID

NCT05682755

Run by

Sichuan University

People needed

77

Starts

2022-12-22

Expected to finish

2026-12-31

Last updated by the study team

2023-01-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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