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

NCT06133192 | Unknown Phase 2 DMC

• 1 other identifier: 2023-508614-41-00
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Graft Vs Host Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• steroid cumulative dose

  at 6 months from randomization

• infections

  at 6 months from randomization

• chronic GVHD

  at 12 months from randomization

• non-relapse mortality

  at 12 months from randomization

• relapse

  at 12 months from randomization

Study Arms (2)

Steroids alone

ACTIVE COMPARATOR

Steroids 2 mg/kg/day

Drug: Steroids

ECP + steroids

EXPERIMENTAL

Steroids 2 mg/kg abd ECP x 2 per week for 1 months and once a week for 2 months

Drug: Uvadex

Interventions

Uvadex DRUG

Uvadex use for ECP

ECP + steroids

Steroids DRUG

steroids 2 mg/kg/d

Steroids alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• \- 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,
• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Methoxsalen; Steroids

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Furocoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PU-PH

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: January 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: January 1, 2026
• Last Updated: November 15, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)