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

NCT03204721 | Completed DMC

• 1 other identifier: 2016/1130
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Graft-Versus-Host Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of survivors the first year after transplantation

  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

  Through study completion, and until 1 year after study start

• Quality of life (QoL) the first year after transplantation

  Through study completion, and until 1 year after study start

• Assessment of vitamin A derivatives

  From randomization to 3 months after transplantation

• Determination of microbiota

  Through study completion, and until 1 year after study start

Study Arms (2)

Extracorporeal photophoresis

ACTIVE COMPARATOR

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)

Controll

NO INTERVENTION

No procedure

Interventions

Extracorporeal photophoresis (ECP) OTHER

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

Extracorporeal photophoresis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• (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
• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Tobias Gedde-Dhl

Oslo, Norway

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Photopheresis

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

PUVA Therapy; Ultraviolet Therapy; Phototherapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant hematologist MD,PhD

Model Details: Patients admitted for allogeneic stamcelltransplantation who consent participation in the study are randomized 1:1, either to receive ECP or no-ECP

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: July 2, 2017
• Study Start: June 21, 2017
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)