NCT05140616

Study of Chidamide for Steroid-resistant/Steroid-dependent Severe cGVHD

Status unknown Phase 1, PHASE2 Last updated 1 December 2021

What this trial tests

Phase 1, PHASE2 trial testing Chidamide in Safety and Efficacy in 20 participants. Status unknown.

Timeline

31 May 2021

Primary endpoint
31 May 2024

31 May 2024

Quick facts

Lead sponsor	The First Affiliated Hospital of Soochow University
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	31 May 2021
Primary completion	31 May 2024
Estimated completion	31 May 2024
Sites	1 location across China

Drugs / interventions tested

• Chidamide — full drug profile →

Conditions studied

• Safety and Efficacy — all drugs for Safety and Efficacy →

Sponsor

The First Affiliated Hospital of Soochow University

Who can join

Adults 18 to 59, any sex, with Safety and Efficacy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is one of the most important and effective methods for the treatment of hematologic malignancies.Chronic graft-versus-host disease (cGVHD) is a serious complication of allogeneic stem cell transplantation with few effective options available after failure of corticosteroids. It is a leading cause of late nonrelapse mortality for transplant patients, also contributing to morbidity and a decrease in quality of life.Corticosteroids, the standard frontline treatment, are typically administered for a median of 2 to 3 years, leading to substantial morbidity. An effort to decrease corticosteroid doses has led to their use in combination with other immunosuppressants, such as cyclosporine, tacrolimus, and sirolimus, in frontlineor second-line settings, despite a lack of clinical evidence supporting additional efficacy after combining these agents with corticosteroids. B and T cells play a rolein the pathophysiology of cGVHD. Previous studies have shown that low-dose histone deacetylase inhibitors (HDACi) have a negative immune regulation in GVHD while maintain the GVL effect. Chidamide is one of new HDACis in China, the previous studies suggested that low dose Chidamide could reduce condition of cGVHD mice by regulating the immune homeostasis of follicular helper T (Tfh) cells. Chidamide also has effects on the regulation of antigen presenting cells, the activation donor T cells, the release of proinflammatory cytokines and the function of Treg cells. Furthermore, low-dose Chidamide has the potential to maintain GVL effects. In preclinical models,Chidamide reduced severity of cGVHD. Based on the biological rationale and preclinical data, a study was designed to evaluate the safety and efficacy of Chidamide in patients with cGVHD who was steroid-resistant/steroid-dependent .

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Epigenetic regulation in hematopoiesis and its implications in the targeted therapy of hematologic malignancies.
   Zhao A, Zhou H, Yang J, Li M, et al · · 2023 · cited 81× · PMID 36797244 · DOI 10.1038/s41392-023-01342-6
2. Therapeutic potential of tucidinostat, a subtype-selective HDAC inhibitor, in cancer treatment.
   Sun Y, Hong JH, Ning Z, Pan D, et al · · 2022 · cited 58× · PMID 36120308 · DOI 10.3389/fphar.2022.932914