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

NCT ID: NCT03605940

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2022-04-01

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.

Conditions

Acute-graft-versus-host Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

corticosteroids + ECP

Group Type: EXPERIMENTAL

Methoxsalen + ECP device

Intervention Type: COMBINATION_PRODUCT

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

Corticosteroids

Intervention Type: DRUG

2 mg/kg/day

Contrôl group

corticosteroids alone

Group Type: ACTIVE_COMPARATOR

Corticosteroids

Intervention Type: DRUG

2 mg/kg/day

Interventions

Methoxsalen + ECP device

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

Intervention Type: COMBINATION_PRODUCT

Corticosteroids

2 mg/kg/day

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Marie-Thérèse RUBIO, PU-PH

Role: CONTACT

m.rubio@chru-nancy.fr

0383153282

Other Identifiers

PSS2017/PCE-aGVHD-RUBIO/VS

Identifier Type: OTHER

Identifier Source: secondary_id

2017-005162-22

Identifier Type: -

Identifier Source: org_study_id