NCT05991973

Low-dose Chidamide Maintenance Therapy After Allo-HSCT for T-cell Acute Lymphoblastic Leukemia or T-cell Lymphomas

A Phase ll, Multi-center, Single-arm Clinical Study of Low-dose Chidamide Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for T-cell Acute Lymphoblastic Leukemia or T-cell Lymphomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 14 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Clinical Study on the Safety and Effectiveness of low-dose chidamide maintenance therapy after allogeneic hematopoietic stem cell transplantation for T-cell acute lymphoblastic leukemia or T-cell lymphomas.

Detailed description

This is a phase ll, multi-center, single-arm clinical study.This study is indicated for high-risk of T-cell acute lymphoblastic leukemia or T-cell lymphomas patients. It aims to evaluate the safety and effectiveness of low-dose chidamide maintenance therapy after allogeneic hematopoietic stem cell transplantation for T-cell acute lymphoblastic leukemia or T-cell lymphomas to prevent relapse. 44 patients will be enrolled. The clinical end points include relapse-free survival, acute or chronic GVHD, non-relapse mortality, and overall survival, etc.

Conditions

• T Lymphoblastic Leukemia/Lymphoma

Interventions

Type	Name	Description
DRUG	Chidamide	Chidamide was initiated between days +30 and +100 post-transplant at 10 mg twice weekly (BIW), continued for up to 2 years (24 courses, 4 weeks as a course) or until relapse, intolerable toxicity, or withdrawal. The dose could be escalated to a maximum of 20 mg BIW if MRD became positive during treatment. Donor lymphocyte infusion (DLI) was permitted in cases of MRD positivity.

Timeline

• Start date: 2023-07-15
• Primary completion: 2025-06-01
• Completion: 2025-07-01
• First posted: 2023-08-15
• Last updated: 2025-12-05

Locations

1 site across 1 country: China