Chidamide treatment to prevent leukemia recurrence after stem cell transplant

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

This study is testing if a medication called chidamide can help prevent leukemia from coming back in patients with high-risk acute myeloid leukemia after they have a stem cell transplant.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 77 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Sichuan University (Academic / other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT05682755 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of chidamide maintenance therapy in patients with high-risk acute myeloid leukemia (AML) who have undergone allogeneic hemopoietic stem-cell transplantation (allo-HSCT). Participants will receive oral chidamide for up to 180 days post-transplant to assess its impact on reducing recurrence rates and the incidence of graft-versus-host disease (GVHD). The study is designed as a Phase I/II trial, focusing on both safety and effectiveness in this vulnerable patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who have undergone allo-HSCT and achieved complete remission.

Not a fit: Patients with central nervous system involvement or serious functional damage to vital organs may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of leukemia recurrence and improve overall survival for high-risk AML patients after transplantation.

How similar studies have performed: While this approach is novel in the context of AML post-transplant, similar studies in other hematological malignancies have shown promising results with maintenance therapies.

Eligibility criteria

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.

Where this trial is running

Chengdu, Sichuan

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

Conditions Leukemia, Myeloid, Acute