Prevention of GVHD in Patients Treated With Allogeneic SCT: Possible Role of Extracorporeal Photophoresis

Graft-Versus-Host Disease Clinical Trial

— GVHD  

Official title:

Prevention of Graft-versus-host Disease in Patients Treated With Allogeneic Stem Cell Transplantation: Possible Role of Extracorporeal Photophoresis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03204721
• Other study ID #: 2016/1130
• Status: Completed
• Phase: N/A
• Start date: June 21, 2017
• Est. completion date: April 30, 2021

Study information

• Verified date: February 2022
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main aim is to test the preventive use of extracorporeal photophoresis (ECP) against development of graft-versus-host disease (GVHD) in patients undergoing allogeneic stem cell transplantation for hematological malignancy.

Description:

Allogeneic stem cell transplantation represents the only available long-term control and possible cure of a number of hematological malignancies. A major obstacle to this treatment is the development of graft-versus-host disease (GVHD), affecting the majority of transplanted patients to some extent. Today, combinations of various cytotoxic and immunosuppressive drugs are used to prevent and treat GVHD, but many of them are associated with severe side-effects. Extracorporeal photophoresis (ECP) offers an alternative to chemo- and immunosuppressive therapy and confers apparently only mild side effects. The postulated rationale of ECP is to treat the patient's white blood cells ex vivo with ultraviolet irradiation after sensitization with 8-methoxypsoralen to dampen their immunoactivity. After engraftment the intervention group receives 2 consecutive ECP every week in 2 weeks then 1 ECP every week in 4 weeks ( a total of 8 ECP procedures).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provide written consent to participate

• Understand Norwegian or English

• No previous history of malignant disease

• No contraindication to ECP-treatment or undergone previous ECP treatment

Exclusion Criteria:

• (in addition to those regarding eligibility for transplantation itself):

• Unwilling to provide written consent to participate

• Unable to cooperate as judged by the responsible physician

• ECOG status > 2 at time of inclusion

• Using anti-inflammatory or cytotoxic drugs other than those that are part of the treatment of the current hematological malignancy

• Known allergy to psoralens or citrate products

• Splenectomy

• Pregnancy/lactating

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-Versus-Host Disease

Intervention

Other:
• Extracorporeal photophoresis (ECP)
The treatment procedure of ECP consists of three steps. First, the leukocytes are removed by apheresis; second, the mononuclear cells are primed with the photosensitizing agent 8-methoxypsoralen; then third, these cells are exposed to radiation with ultraviolet A light before they are re-infused into the patient

Locations

Country	Name	City	State
Norway	Tobias Gedde-Dhl	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduce the frequency of GVHD by preventive treatment with ECP of patients undergoing allogeneic stem cell transplantation for hematological malignancies	GVHD is measured according to internationally recognized criteria	up to 1 year after allogeneic stamcell transplantation
Secondary	Number of survivors the first year after transplantation	In the follow-up periode mortality rate in both groups is registered	Through study completion, and until 1 year after study start
Secondary	Number of patients who relapsed the first year after transplantation Number of patients who relapsed the first year after transplantation Number of patients who relapsed the first year after transplantation	In the follow-up periode relapse rate in both groups is registered	Through study completion, and until 1 year after study start
Secondary	Quality of life (QoL) the first year after transplantation	In the follow-up periode EORTC-QLQ-C30 scores in both groups are registered	Through study completion, and until 1 year after study start