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)

Central Hospital, Nancy, France

Status and phase: Unknown; Phase 2

Conditions: Acute-graft-versus-host Disease

Treatments: Drug: Corticosteroids; Combination Product: Methoxsalen + ECP device

Study type: Interventional

Funder types: Other

Identifiers

NCT03605940

PSS2017/PCE-aGVHD-RUBIO/VS (Other Identifier)

2017-005162-22

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Experimental group

Experimental group

Description:

corticosteroids + ECP

Treatment:

Combination Product: Methoxsalen + ECP device

Drug: Corticosteroids

Contrôl group

Active Comparator group

Description:

corticosteroids alone

Treatment:

Drug: Corticosteroids