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

NCT00524953 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-06-11

No results posted yet for this study

Summary

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.

Conditions

  • Allogeneic Transplantation (Non T-cell Depleted)

Interventions

DEVICE

EUMATRON - EN 600 NT

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)

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Reuven Or, MD · Bone Marrow transplantation, cancer immunotherapy & immunobiology research center, Hadassah University Hospital, Ein - Kerem, Jerusalem, Israel

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00524953 on ClinicalTrials.gov