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

Acute-graft-versus-host Disease Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03605940
• Other study ID #: 2017-005162-22
• Secondary ID: PSS2017/PCE-aGVH
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 1, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: July 2018
• Source: Central Hospital, Nancy, France
• Contact: Marie-Thérèse RUBIO, PU-PH
• Phone: 0383153282
• Email: m.rubio[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute-graft-versus-host Disease
• Graft vs Host Disease

Intervention

Combination Product:
• Methoxsalen + ECP device
2 sessions per week during 4 weeks and 1 session per week during 8 weeks

Drug:
• Corticosteroids
2 mg/kg/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probability of being free of treatment failure (probability of survival without relapse, additional line of treatment for aGVHD and systemic therapy for chronic GVHD)		6 months
Secondary	mean of the cumulative dose of steroids		Month 1- Month 2 - Month 3 - Month 6 - Month 12
Secondary	cumulative incidence rate of infections		Month 6 - Month 12
Secondary	cumulative incidence of thromboembolic complications		Month 3
Secondary	incidence of chronic GVHD		Month 6 - Month 12
Secondary	severity of chronic GVHD		Month 6 - Month 12
Secondary	incidence rate of non-relapse mortality		Month 6 - Month 12
Secondary	incidence of disease relapse		Month 6 - Month 12
Secondary	disease-free survival		Month 6 - Month 12
Secondary	overall survival		Month 6 - Month 12
Secondary	scores of health-related quality of life using the French validated FACT-BMT		Month 3 - Month 6 - Month 12
Secondary	Total T cells number		Month 3 - Month 6 - Month 12
Secondary	CD4 T cells number		Month 3 - Month 6 - Month 12
Secondary	CD8 T cells number		Month 3 - Month 6 - Month 12
Secondary	B cells number		Month 3 - Month 6 - Month 12
Secondary	NK cells number		Month 3 - Month 6 - Month 12
Secondary	gamma globulin number		Month 3 - Month 6 - Month 12