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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-21

Study Completion Date

2021-04-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Graft-Versus-Host Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Extracorporeal photophoresis (ECP)

Intervention Type 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

Controll

No procedure

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No