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

Graft Vs Host Disease Clinical Trial

— COPAVEHDI  

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 Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06133192
• Other study ID #: 2023-508614-41-00
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2024
• Est. completion date: January 2026

Study information

• Verified date: October 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: January 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years,

• allogeneic hematopoietic stem cell transplantation received (from any type of graft and donor) after malignant or non malignant disease

• patient suffering from Grade II acute GVHD with skin +/- high GI involvement (stage 2-3 skin + upper gastrointestinal tract or skin stage 3) in the 3 months following stem cell transplantation

• patient requiring first line treatment for acute GVHD

• patient able to start PCE therapy in the 3 days after randomization

• validation of the presence of a peripheral or central venous access (its type should be conform to the recommendations described in the Therakos Cellex operator manual), allowing to perform PCE sessions weekly during 3 months. In the absence of appropriate preexisting central line at inclusion, peripheral access will be preferred.

• leukocytes > 1.5 G/l, platelets > 30 G/l, hematocrit > 27% (blood transfusion are permitted), based on the last available blood testing results,

• patient with French Health Insurance,

• patient informed about the clinical trial content and organization,

• informed consent form signed.

Exclusion Criteria:

• - Grade 1 acute GVHD,

• acute GVH grade > II or acute GVH with lower gastrointestinal tract or with liver involvement,

• relapse of the hematologic disease at time of acute GVHD,

• uncontrolled ongoing infection at time of inclusion: bacterial or fungal infections, CMV reactivation with increasing CMV viral load,

• HIV positivity or replicative HBV or HCV infection (based on pre-transplant assessment),

• patient with allergy or contraindications to UVADEX, extracorporeal photopheresis, steroids, or posaconazole (see details in the study protocol),

• woman of childbearing age without efficient contraceptive method, pregnancy or breast feeding woman,

• patient with history of profound venous thrombosis in the last 5 years,

• patient included in another acute GVHD prospective clinical trial.

Related Conditions & MeSH terms

• Graft Vs Host Disease

Intervention

Drug:
• Uvadex
Uvadex use for ECP
• Steroids
steroids 2 mg/kg/d

Locations

Country	Name	City	State
France	CHRU de Nancy	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from treatment failure	To be alive, without disease relapse, without second line treatment for acute GVHD and without systemic treatment for chronic GVHD	at 6 months from randomization
Secondary	steroid cumulative dose	cumulative dose of steroids over time	at 6 months from randomization
Secondary	infections	incidence rate of infections (bacteremia, septicemia, fungal infections, parasite and virus	at 6 months from randomization
Secondary	chronic GVHD	incidence and severity of chronic GVHD	at 12 months from randomization
Secondary	non-relapse mortality	non-relapse mortality rate	at 12 months from randomization
Secondary	relapse	incidence of disease relapse	at 12 months from randomization
Secondary	overall survival	overall survival logrank	at 12 months from randomization