Phase I Clinical Trial to Assess Safety of UV Phototherap... | NCT00524953

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

NCT00524953

Sponsor

Hadassah Medical Organization

Status

Withdrawn

Last Update Posted

Jun 11, 2015Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Allogeneic Transplantation (Non T-cell Depleted)

Interventions

EUMATRON - EN 600 NT

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Sep 4, 2007

First Submission Date that Met QC Criteria

Sep 4, 2007

First Posted Date

Sep 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2015

Last Update Posted Date

Jun 11, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I	Experimental	10 patients after allogeneic BMT (non T-depleted).	Device: EUMATRON - EN 600 NT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EUMATRON - EN 600 NT	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)

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Reuven Or, MD	Bone Marrow transplantation, cancer immunotherapy & immunobiology research center, Hadassah University Hospital, Ein - Kerem, Jerusalem, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem			Israel