Clinical Trials Logo
  1. Home
  2. Graft vs Host Disease
  3. NCT06133192

Steroids Versus ECP and Steroids as First-line Treatment of Grade II Acute GVHD — COPAVEHDI  

Graft Vs Host Disease Clinical Trial

Official title:
A Multi-center Randomized Phase II Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporeal Photopheresis as First-line Treatment of Grade II Acute Graft-versus-host Disease With Skin Involvement Occuring After Allogeneic Stem Cell Transplantation

Clinical Trial Summary

The goal of this clinical trial is to compare as a first line of grade II skin acute GVHD sconventional treatment with steroids alone to a combination of steroids and extracoporeal photopheresis (ECP) The primary end point will compare Freedom from treatment failure at 6 months from randomization as defined by meeting all the following 4 conditions: - to be alive - without relapse of the hematological disease - without having required a new line of treatment for acute GVHD - without initiating a systemic treatment for chronic GVHD.

Clinical Trial Description

A multi-center randomized phase II study comparing corticosteroids alone (standard of care) versus corticosteroids and extracorporeal photopheresis as first-line treatment of Grade II acute graft-versus-host disease with skin +/- upper gastrointestinal involvement occurring after allogeneic stem cell transplantation Corticosteroids will be started at 2 mg/kg in both arms and will be tapered once acute GVHD achieves complete remission according to strict protocol guidelines (-20% of the daily dose per week until 1 mg/kg and then 10 mg twice a day in order to stop steroids within 2 to 3 months from randomization). Extracorporeal Photopheresis (ECP) will be performed in the experimental arm : 2 sessions/week during 4 weeks then 1 session/week during 8 weeks), i.e. a total of 16 ECP sessions in 12 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06133192
Study type Interventional
Source Central Hospital, Nancy, France
Contact
Status Not yet recruiting
Phase Phase 2
Start date January 2024
Completion date January 2026
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06080490 - Tacrolimus Blood Concentration and Transplant-related Outcomes in Pediatric HSCT Recipients
Completed NCT00001637 - Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults Phase 2
Withdrawn NCT04728646 - Evaluation of Dextenza in Patients With Ocular GVHD and Effects on Ocular Surface Disease Outcomes Phase 4
Suspended NCT01972438 - A Randomized, Controlled, Double-masked, Clinical Trial of Autologous Serum Eye Drops for Severe Ocular Chronic Graft-versus-host Disease (GVHD) in Hematopoietic Stem Cell Transplant (HSCT) Patients Phase 1/Phase 2
Completed NCT01221766 - Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease N/A
Recruiting NCT01764100 - Mesenchymal Stromal Cells (MSCs) for the Treatment of Graft Versus Host Disease (GVHD) Phase 1
Completed NCT00760981 - A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease Phase 1
Terminated NCT00298324 - Myfortic - Treatment for Extensive cGvHD Phase 3
Completed NCT00224874 - Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302) Phase 2
Completed NCT00023530 - Blood and Marrow Transplant Clinical Research Network N/A
Completed NCT00023491 - Potential of Transplanted Stem Cells to Mature Into Salivary Gland and Cheek Cells N/A
Recruiting NCT05111834 - IRENE-G Study: Impact of Resistance Exercise and Nutritional Endorsement on GvHD Symptoms N/A
Completed NCT02841995 - A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease Phase 2
Recruiting NCT06143501 - Alterations in Intestinal Microbiota, Metabolites, and Immune Cells in Allo-HSCT
Recruiting NCT04622956 - GVHD Prophylaxis With Methotrexate in Haploidentical HCT Using Posttransplant Cyclophosphamide Phase 1/Phase 2
Recruiting NCT03340155 - Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases N/A
Recruiting NCT03836690 - Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation Phase 1
Not yet recruiting NCT06450925 - Vitamin A Supplementation in Allogeneic Stem Cell Transplantation. N/A
Not yet recruiting NCT02506231 - The Effect of Folinic Acid Rescue Following MTX GVHD Prophylaxis on Regimen Related Toxicity and Transplantation Outcome Phase 2/Phase 3
Recruiting NCT01042509 - Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease N/A