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

Study Overview
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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.

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).

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

Conditions
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Graft-Versus-Host Disease

Intervention / Treatment
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* Other: Extracorporeal photophoresis (ECP)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extracorporeal photophoresis<br>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)<br>* 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<br>|
| No Intervention: Controll<br>No procedure | |

What is the study measuring?
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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 |