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Chidamide Maintenance to Prevent Relapse After Allogeneic Hematopoietic Stem Cell Transplantation in Acute T-Lymphoblastic Leukemia/Lymphoma

NCT07774377 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-08-19

No results posted yet for this study

Summary

This study evaluates whether chidamide maintenance therapy can effectively reduce the risk of relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with high-risk T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma (T-ALL/LBL). Chidamide is an oral selective histone deacetylase inhibitor (HDACi) with dual anti-tumor and immunomodulatory effects.

Participants will be randomized in a 1:1 ratio to receive either chidamide maintenance for up to 24 months or standard follow-up without maintenance. The primary endpoint is relapse-free survival (RFS). Key secondary endpoints include cumulative incidence of relapse (CIR), overall survival (OS), non-relapse mortality (NRM), incidence and severity of graft-versus-host disease (GVHD), safety profile, and patient-reported outcomes (PROs).

This multicenter, open-label, randomized controlled trial aims to provide high-level evidence on the efficacy and safety of chidamide as a post-transplant maintenance strategy. Approximately 132 patients will be enrolled across 6 transplant centers in China.

Conditions

  • T-Cell Acute Lymphoblastic Leukemia
  • T-Cell Lymphoblastic Lymphoma

Interventions

DRUG

Chidamide

Oral chidamide 10 mg twice weekly (BIW) starting at Day +30 to +100 post-transplant. Treatment cycles are 4 weeks each, for a total of 26 cycles (approximately 24 months). Dose may be escalated to 20 mg BIW in case of MRD positivity.

OTHER

Control Group

Standard follow-up without maintenance therapy. Regular assessments are performed per the same schedule as the treatment group.

Sponsors & Collaborators

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Yanmin Zhao, MD · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2028-08-15
Completion
2029-08-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07774377 on ClinicalTrials.gov