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

NCT05140616 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-12-01

No results posted yet for this study

Summary

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 .

Conditions

  • Safety and Efficacy

Interventions

DRUG

Chidamide

After screening according to inclusion and exclusion criteria, patients meeting the criteria were enrolled. Treatment regimen: Chidamide 15mg biw po, lasted for 8 weeks. Pretransplant use of Chidamide for reasons other than cGVHD, such as for the treatment of leukemia or lymphoma, was permitted.All patients received systemic corticosteroid therapy for cGVHD prior to and during the study; concomitant use of other immunosuppressive therapies was also permitted, however, pre-existing corticosteroid and immunosuppressant doses must have been stable for 14 days before initiating Chidamide. Doses of concomitant corticosteroids and immunosuppressants could be tapered during the study as clinically indicated.

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • depei Wu · the first affiliated hospital of Soochow Uninersity

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-31
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • China

Study Locations

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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 NCT05140616 on ClinicalTrials.gov