Phase I Clinical Trial to Assess Safety of UV Phototherapy for the Prevention of GVHD Post Allogeneic SCT

Study Overview
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Brief Summary
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The primary goal of thos study is to assess safety of Ultraviolet (UV) Phototherapy for the Prevention of Graft versus Host Disease after allogeneic stem cell transplantation (Phase I - Clinical trial). Following allogeneic BMT, patients will be placed on standard GVHD preventive therapy (cyclosporine). Secondary goals - monitoring immune system recovery the influence of stem cells origin on therapy and/orGVHD prevention the influence of UV-c treatment on survival clinical data and samples will be collected, during UV-c therapy, 100 days after discharge & 6 months after discharge - to examine the long-term effect of UV-c treatment on the patient's GVHD status.

Detailed Description
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Treatment will be given with a portable, easy to operate device named EUMATRON. this device contains a UV- lamp. 250 cc of blood from a peripheric vein is going through the device into a bottle with Low dose Heparin and returning to patient's body. procedure takes  20 minutes.

Official Title
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Phase I - Clinical Trial to Assess Safety of Ultraviolet (UV) Phototherapy for the Prevention of Graft Versus Host Disease After Allogeneic Stem Cell Transplantation

Conditions
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Allogeneic Transplantation (Non T-cell Depleted)

Intervention / Treatment
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* Device: EUMATRON - EN 600 NT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients post non T cell depleted allogeneic stem cell transplantation Exclusion Criteria: morbidity unrelated to GVHD patients in an hemodynamic unstable condition acute uncontrolled bleeding patients undergoing dialysis

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>10 patients after allogeneic BMT (non T-depleted). | Device: EUMATRON - EN 600 NT<br>* frequency - once a week, starting 4 days after transplantation for four weeks (total of 4 treatments) each treatment will last  20 minutes. In addition - standard GVHD preventive protocol will be given to patients (including cyclosporine and steroids - if necessary)<br>* Other names: EN 600 NT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability of UV-c phototherapy for the Prevention of Graft versus Host Disease after allogeneic stem cell transplantation |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| monitoring immune system recovery, influence on survival rates, influence of stem cells origin on treatment & prevention of GVHD |  | 100 days, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allogeneic bone marrow transplantation, non-T-cell depleted, UV-c, GVHD