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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00524953
First received: September 4, 2007
Last updated: June 10, 2015
Last verified: August 2007
  Purpose

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.


Condition Intervention Phase
Allogeneic Transplantation (Non T-cell Depleted)
Device: EUMATRON - EN 600 NT
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase I - Clinical Trial to Assess Safety of Ultraviolet (UV) Phototherapy for the Prevention of Graft Versus Host Disease After Allogeneic Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • safety and tolerability of UV-c phototherapy for the Prevention of Graft versus Host Disease after allogeneic stem cell transplantation [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • monitoring immune system recovery, influence on survival rates, influence of stem cells origin on treatment & prevention of GVHD [ Time Frame: 100 days, 6 months ]

Enrollment: 0
Study Start Date: September 2007
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
10 patients after allogeneic BMT (non T-depleted).
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)
Other Name: EN 600 NT

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   14 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524953

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Reuven Or, MD Bone Marrow transplantation, cancer immunotherapy & immunobiology research center, Hadassah University Hospital, Ein - Kerem, Jerusalem, Israel
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00524953     History of Changes
Other Study ID Numbers: UV-GVHD - HMO-CTIL
Study First Received: September 4, 2007
Last Updated: June 10, 2015
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
allogeneic bone marrow transplantation
non-T-cell depleted
UV-c
GVHD

ClinicalTrials.gov processed this record on September 02, 2015