Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-host-Disease — GVHD-TReG

Chronic Graft vs Host Disease Clinical Trial

Official title:
A Phase I Trial of Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-Host-Disease in Patients Who do Not Obtain Complete Remission With Ruxolitinib

Status Completed

Clinical Trial Summary

A Phase I Trial of Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-Host-Disease in patients who do not obtain complete remission with ruxolitinib

Clinical Trial Description

The study design is based on a phase I trial in Spanish. A number of 16 patients will be included to assess the safety and maximum tolerated dose-level of donor regulatory enriched T cell (Treg) in steroid-refractory chronic graft versus host disease (cGVHD) patients who did not obtain complete remission under treatment with ruxolitinib. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03683498
Study type	Interventional
Source	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Contact
Status	Completed
Phase	Phase 1
Start date	September 25, 2018
Completion date	March 24, 2022

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See also
Status	Clinical Trial	Phase
Completed	`NCT01221766` - Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease	N/A
Active, not recruiting	`NCT02067832` - Predictive Biomarkers For Pediatric Chronic Graft-Versus-Host Disease
Active, not recruiting	`NCT02759731` - Study of Baricitinib, a JAK1/2 Inhibitor, in Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation	Phase 1/Phase 2
Recruiting	`NCT05095649` - Donor Regulatory T-cells for cGVHD in Patients Who do Not Obtain Complete Remission With Ruxolitinib	Phase 2
Terminated	`NCT04852692` - A Study to Investigate the Comparative Effectiveness of Ibrutinib in Steroid Dependent/Refractory cGVHD Participants
Recruiting	`NCT02669251` - Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation	Phase 1/Phase 2