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

Primary Purpose

Graft-Versus-Host Disease

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Extracorporeal photophoresis (ECP)
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Graft-Versus-Host Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tobias Gedde-Dhl

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Extracorporeal photophoresis

Controll

Arm Description

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 procedure

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of survivors the first year after transplantation
In the follow-up periode mortality rate in both groups is registered
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
Quality of life (QoL) the first year after transplantation
In the follow-up periode EORTC-QLQ-C30 scores in both groups are registered

Full Information

First Posted
June 1, 2017
Last Updated
February 14, 2022
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03204721
Brief Title
Prevention of GVHD in Patients Treated With Allogeneic SCT: Possible Role of Extracorporeal Photophoresis
Acronym
GVHD
Official Title
Prevention of Graft-versus-host Disease in Patients Treated With Allogeneic Stem Cell Transplantation: Possible Role of Extracorporeal Photophoresis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 21, 2017 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft-Versus-Host Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients admitted for allogeneic stamcelltransplantation who consent participation in the study are randomized 1:1, either to receive ECP or no-ECP
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extracorporeal photophoresis
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Controll
Arm Type
No Intervention
Arm Description
No procedure
Intervention Type
Other
Intervention Name(s)
Extracorporeal photophoresis (ECP)
Intervention Description
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
Primary Outcome Measure Information:
Title
Reduce the frequency of GVHD by preventive treatment with ECP of patients undergoing allogeneic stem cell transplantation for hematological malignancies
Description
GVHD is measured according to internationally recognized criteria
Time Frame
up to 1 year after allogeneic stamcell transplantation
Secondary Outcome Measure Information:
Title
Number of survivors the first year after transplantation
Description
In the follow-up periode mortality rate in both groups is registered
Time Frame
Through study completion, and until 1 year after study start
Title
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
Description
In the follow-up periode relapse rate in both groups is registered
Time Frame
Through study completion, and until 1 year after study start
Title
Quality of life (QoL) the first year after transplantation
Description
In the follow-up periode EORTC-QLQ-C30 scores in both groups are registered
Time Frame
Through study completion, and until 1 year after study start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geir E Tjønnfjord, Prof,MD,PhD
Organizational Affiliation
Oslo University Hospital HF, Department of Haematology Rikshospitalet
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Per Ole Iversen, Prof,MD,PhD
Organizational Affiliation
Oslo University Hospital HF, Department of Haematology Rikshospitalet
Official's Role
Study Chair
Facility Information:
Facility Name
Tobias Gedde-Dhl
City
Oslo
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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