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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00524953
First received: September 4, 2007
Last updated: August 18, 2008
Last verified: August 2007

September 4, 2007
August 18, 2008
September 2007
Not Provided
safety and tolerability of UV-c phototherapy for the Prevention of Graft versus Host Disease after allogeneic stem cell transplantation [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00524953 on ClinicalTrials.gov Archive Site
monitoring immune system recovery, influence on survival rates, influence of stem cells origin on treatment & prevention of GVHD [ Time Frame: 100 days, 6 months ]
Same as current
Not Provided
Not Provided
 
Phase I Clinical Trial to Assess Safety of UV Phototherapy for the Prevention of GVHD Post Allogeneic SCT
Phase I - Clinical Trial to Assess Safety of Ultraviolet (UV) Phototherapy for the Prevention of Graft Versus Host Disease After Allogeneic Stem Cell Transplantation

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Allogeneic Transplantation (Non T-Cell 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
Experimental: I
10 patients after allogeneic BMT (non T-depleted).
Intervention: Device: EUMATRON - EN 600 NT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
10
September 2008
Not Provided

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
Both
14 Years to 70 Years
No
Contact: Reuven Or, MD 972-2-6778357 reuvenor@hadassah.org.il
Israel
 
NCT00524953
UV-GVHD - HMO-CTIL
No
Not Provided
Hadassah Medical Organization
Not Provided
Principal Investigator: Reuven Or, MD Bone Marrow transplantation, cancer immunotherapy & immunobiology research center, Hadassah University Hospital, Ein - Kerem, Jerusalem, Israel
Hadassah Medical Organization
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP