Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML

NCT07304232 | Recruiting Phase 2

• 1 other identifier: IIT2025057
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 5

Brief Summary

This study is a Phase II clinical trial designed to evaluate the efficacy and safety of Chidamide as maintenance therapy in high-risk acute myeloid leukemia (AML) patients following stem cell transplantation. Trial Design: The trial is a single-arm, open-label study. The experimental group plans to enroll 67 patients, while the control group (observation only) also plans to enroll approximately 67 patients, with randomization. All patients must have received induction chemotherapy prior to enrollment and may or may not have received consolidation therapy. The chemotherapy regimen was determined by the treating physician. Patients had received induction and/or consolidation therapy, achieved remission, and underwent stem cell transplantation. Study Objectives: The study aims to assess the impact of Chidamide maintenance therapy on recurrence-free survival (RFS), overall survival (OS), and the duration of complete remission. The study will also evaluate the tolerability and toxicity profile of this regimen, as well as the effect of maintenance therapy on the dynamics of minimal residual disease (MRD).

Conditions

Allogeneic Hematopoietic Cell Transplantation (HCT); AML (Acute Myeloid Leukemia)

Outcome Measures

Primary Outcomes (1)

• Recurrence-Free Survival(RFS)

  the rate from first dose administration until the first achievement of complete remission (CR) or complete remission with incomplete recovery (CRi), followed by either confirmed relapse or death from any cause, whichever occurs earlier.

  2years

Secondary Outcomes (5)

• Overall Survival (OS)

  2years

• Event-Free Survival (EFS)

  2years

• Duration of Response (CRd)

  2years

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  2years

• Minor residual lesions (MRD) Response Rate

  2years

Study Arms (2)

Chidamide treatment group

EXPERIMENTAL

Patients in the experimental group receive Chidamide at a dose of 10 mg/day, administered orally for the first 5 days of each week, followed by a 2-day treatment-free interval.

Drug: Chidamide

Observation group

NO INTERVENTION

Observation group

Interventions

Chidamide DRUG

Patients in the experimental group receive Chidamide at a dose of 10 mg/day, administered orally for the first 5 days of each week, followed by a 2-day treatment-free interval.

Chidamide treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AML patients meeting the following conditions (diagnosed per WHO 2022 AML criteria) who achieved first complete remission (CR) with intermediate-/high-risk cytogenetic abnormalities at the time of allogeneic transplantation.
• Patients must achieve complete remission (CR) post-transplantation.
• Enrollment must occur between 60 and 100 days after transplantation.
• Age 18 to 75 years.
• ECOG performance status 0-1.
• Serum creatinine \< 1.5 × ULN (upper limit of normal).
• Serum direct bilirubin \< 1.5 mg/dL (except in Gilbert's syndrome).
• ALT and AST \< 2.5 × ULN.
• Ability to understand and provide written informed consent.

You may not qualify if:

• Receipt of any other investigational drugs post-transplantation.
• FLT3 mutation-positive status.
• Central nervous system (CNS) involvement.
• Uncontrolled grade 2-4 graft-versus-host disease (GVHD).
• Uncontrolled active infection.
• Known or suspected hypersensitivity to Chidamide or its excipients.
• Uncontrolled congestive heart failure (CHF) or other concomitant systemic diseases or severe complications that, in the investigator's judgment, would make the patient unsuitable for participation in this study or would significantly compromise the proper assessment of the safety and toxicity of the prescribed regimen.
• Pregnancy or breastfeeding.
• Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (5)

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

NOT YET RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

NOT YET RECRUITING

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300020, China

NOT YET RECRUITING

Tianjin People's Hospital

Tianjin, Tianjin Municipality, 300020, China

NOT YET 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

Central Study Contacts

Jiang Erlie, doctor

CONTACT

+86-15122538106; jiangerlie@ihcams.ac.cn

Liang Chen

CONTACT

+86-13612043271; liangchen@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: December 26, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)