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A Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporal Photopheresis (ECP) as First-line Treatment of Standard II Acute Graft-versus-host Disease (PCE-aGVHD)

Primary Purpose

Acute-graft-versus-host Disease

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Methoxsalen + ECP device

Corticosteroids

About this trial

This is an interventional treatment trial for Acute-graft-versus-host Disease focused on measuring Acute-graft-versus-host Disease, Extracorporal Photopheresis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years ;
Having received an allogeneic stem cell transplantation for any malignant or non-malignant hemopathy and whatever the type of donor and graft.
with grade II acute GVHD with skin involvement (stage 1-3 skin +/- stage 1 gastro intestinal) in the 3 months following the allogeneic stem cell transplantation
acute GVHD in the first line treatment
validation of the presence of peripheral or central venous access allowing to perform 2 ECP per week during 3 months. In the absence of a pre-existing and adpated central catheter at the time of inclusion, peripheral venous access will be preferred
Leucocytes > 1.5 G/L
Platelets > 30 G/L, Haematocrite > 27% (allowed transfusions)
Patient affiliated to a French Social Security regimen
information consent form signed.

Exclusion Criteria:

acute GVHD of grade I
acute GVHD of grade > II
progressive hematologic disease at inclusion
uncontrolled ongoing infection at time of inclusion: bacterial or fungal infections, increasing CMV viral load.
patient with HIV positivity or replicative HBV or HCV infection
Contraindications for UVADEX / photopheresis / stéroids / posaconazole / heparin
Patient with a history of deep venous thrombosis
Pregnancy
Women of child bearing potentiel not using contaception

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Contrôl group

Arm Description

corticosteroids + ECP

corticosteroids alone

Outcomes

Primary Outcome Measures

Probability of being free of treatment failure (probability of survival without relapse, additional line of treatment for aGVHD and systemic therapy for chronic GVHD)

Secondary Outcome Measures

mean of the cumulative dose of steroids

cumulative incidence rate of infections

cumulative incidence of thromboembolic complications

incidence of chronic GVHD

severity of chronic GVHD

incidence rate of non-relapse mortality

incidence of disease relapse

disease-free survival

overall survival

scores of health-related quality of life using the French validated FACT-BMT

Total T cells number

CD4 T cells number

CD8 T cells number

B cells number

NK cells number

gamma globulin number

Full Information

NCT ID

NCT03605940

First Posted

July 21, 2018

Last Updated

July 27, 2018

Sponsor

Central Hospital, Nancy, France

1. Study Identification

Unique Protocol Identification Number

NCT03605940

Brief Title

A Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporal Photopheresis (ECP) as First-line Treatment of Standard II Acute Graft-versus-host Disease

Acronym

PCE-aGVHD

Official Title

A Multi-center Randomized Phase II Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporal Photopheresis (ECP) as First-line Treatment of Standard Risk Grade II Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2018 (Anticipated)

Primary Completion Date

April 1, 2021 (Anticipated)

Study Completion Date

April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Acute graft versus host-disease remains a major cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation. The incidence of grade II to IV acute GVHD ranges from 30 to 50% of the patients transplanted. Steroids remain the standard first line treatment for acute GVHD. Prolonged exposure to steroids is associated to increased risk of infections and of osteoporosis, osteonecrosis and alteration of growth in children. Thus, reducing steroid exposure in order to reduce treatment-related morbidity is another important goal in the management of standard risk aGVHD. Extracoporeal photopheresis (ECP) is active in controlling steroid refractory or dependent acute GVHD. Hypothesis: In this study, the team hypothesizes that addition of ECP to first line treatment with 2 mg/kg steroids of standard risk grade II aGVHD can reduce steroid exposure by increasing the probability of 6 month FFTF including absence of systemic steroids for chronic GVHD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute-graft-versus-host Disease

Keywords

Acute-graft-versus-host Disease, Extracorporal Photopheresis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

corticosteroids + ECP

Arm Title

Contrôl group

Arm Type

Active Comparator

Arm Description

corticosteroids alone

Intervention Type

Combination Product

Intervention Name(s)

Methoxsalen + ECP device

Intervention Description

2 sessions per week during 4 weeks and 1 session per week during 8 weeks

Intervention Type

Drug

Intervention Name(s)

Corticosteroids

Intervention Description

2 mg/kg/day

Primary Outcome Measure Information:

Title

Probability of being free of treatment failure (probability of survival without relapse, additional line of treatment for aGVHD and systemic therapy for chronic GVHD)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

mean of the cumulative dose of steroids

Time Frame

Month 1- Month 2 - Month 3 - Month 6 - Month 12

Title

cumulative incidence rate of infections

Time Frame

Month 6 - Month 12

Title

cumulative incidence of thromboembolic complications

Time Frame

Month 3

Title

incidence of chronic GVHD

Time Frame

Month 6 - Month 12

Title

severity of chronic GVHD

Time Frame

Month 6 - Month 12

Title

incidence rate of non-relapse mortality

Time Frame

Month 6 - Month 12

Title

incidence of disease relapse

Time Frame

Month 6 - Month 12

Title

disease-free survival

Time Frame

Month 6 - Month 12

Title

overall survival

Time Frame

Month 6 - Month 12

Title

scores of health-related quality of life using the French validated FACT-BMT

Time Frame

Month 3 - Month 6 - Month 12

Title

Total T cells number

Time Frame

Month 3 - Month 6 - Month 12

Title

CD4 T cells number

Time Frame

Month 3 - Month 6 - Month 12

Title

CD8 T cells number

Time Frame

Month 3 - Month 6 - Month 12

Title

B cells number

Time Frame

Month 3 - Month 6 - Month 12

Title

NK cells number

Time Frame

Month 3 - Month 6 - Month 12

Title

gamma globulin number

Time Frame

Month 3 - Month 6 - Month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years ; Having received an allogeneic stem cell transplantation for any malignant or non-malignant hemopathy and whatever the type of donor and graft. with grade II acute GVHD with skin involvement (stage 1-3 skin +/- stage 1 gastro intestinal) in the 3 months following the allogeneic stem cell transplantation acute GVHD in the first line treatment validation of the presence of peripheral or central venous access allowing to perform 2 ECP per week during 3 months. In the absence of a pre-existing and adpated central catheter at the time of inclusion, peripheral venous access will be preferred Leucocytes > 1.5 G/L Platelets > 30 G/L, Haematocrite > 27% (allowed transfusions) Patient affiliated to a French Social Security regimen information consent form signed. Exclusion Criteria: acute GVHD of grade I acute GVHD of grade > II progressive hematologic disease at inclusion uncontrolled ongoing infection at time of inclusion: bacterial or fungal infections, increasing CMV viral load. patient with HIV positivity or replicative HBV or HCV infection Contraindications for UVADEX / photopheresis / stéroids / posaconazole / heparin Patient with a history of deep venous thrombosis Pregnancy Women of child bearing potentiel not using contaception

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marie-Thérèse RUBIO, PU-PH

Phone

0383153282

m.rubio@chru-nancy.fr

12. IPD Sharing Statement

Learn more about this trial

A Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporal Photopheresis (ECP) as First-line Treatment of Standard II Acute Graft-versus-host Disease

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