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

NCT ID: NCT00524953

Last Updated: 2015-06-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2013-09-30

Brief 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.

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.

Conditions

Allogeneic Transplantation (Non T-cell Depleted)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

I

10 patients after allogeneic BMT (non T-depleted).

Group Type: EXPERIMENTAL

EUMATRON - EN 600 NT

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: DEVICE

Other Intervention Names

EN 600 NT

Eligibility 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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Principal Investigators

Reuven Or, MD

Role: PRINCIPAL_INVESTIGATOR

Bone Marrow transplantation, cancer immunotherapy & immunobiology research center, Hadassah University Hospital, Ein - Kerem, Jerusalem, Israel

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Countries

Israel

Other Identifiers

UV-GVHD - HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id