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

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

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.

Study Overview

• Status: Completed
• Conditions: Graft-Versus-Host Disease
• Intervention / Treatment: Other: Extracorporeal photophoresis (ECP)

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Tobias Gedde-Dhl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Extracorporeal photophoresis; 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.	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
No Intervention: Controll; No procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Study Chair: Geir E Tjønnfjord, Prof,MD,PhD, Oslo University Hospital HF, Department of Haematology Rikshospitalet; Study Chair: Per Ole Iversen, Prof,MD,PhD, Oslo University Hospital HF, Department of Haematology Rikshospitalet

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2017
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: 2016/1130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No