Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-01-01 @ 6:27 PM
Study NCT ID:
NCT06133192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Steroids Versus ECP and Steroids as First-line Treatment of Grade II Acute GVHD
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPAVEHDI
Brief 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.
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.
Detailed 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: