Allogeneic Transplantation (Non T-cell Depleted)Phase 1NCT00524953
Phase I Clinical Trial to Assess Safety of UV Phototherapy for the Prevention of GVHD Post Allogeneic SCT
A Phase 1 study testing EUMATRON - EN 600 NT in people with Allogeneic Transplantation (Non T-cell Depleted), run by Hadassah Medical Organization at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Allogeneic Transplantation (Non T-cell Depleted)
- What is being tested?
- EUMATRON - EN 600 NT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2007to Sep 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients post non T cell depleted allogeneic stem cell transplantation
Who cannot join
- morbidity unrelated to GVHD
- patients in an hemodynamic unstable condition
- acute uncontrolled bleeding
- patients undergoing dialysis
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- EUMATRON - EN 600 NT
- Keywords
- allogeneic bone marrow transplantation, non-T-cell depleted, UV-c, GVHD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUMATRON - EN 600 NTDevice
Also called 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)
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | 10 patients after allogeneic BMT (non T-depleted). Receives: Device: EUMATRON - EN 600 NT |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability of UV-c phototherapy for the Prevention of Graft versus Host Disease after allogeneic stem cell transplantation
Measured: 6 months
Secondary outcomes (1)
monitoring immune system recovery, influence on survival rates, influence of stem cells origin on treatment & prevention of GVHD
Measured: 100 days, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Transplantation (Non T-cell Depleted)Studies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Reuven Or, MD, Principal investigator, Bone Marrow transplantation, cancer immunotherapy & immunobiology research center, Hadassah University Hospital, Ein - Kerem, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524953
- Sponsor's protocol ID
- UV-GVHD - HMO-CTIL
- Status last verified
- Aug 2007
- First submitted
- 4 Sep 2007
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00524953
- Acronym / sponsor ID
- UV-GVHD - HMO-CTIL
- Keywords
- allogeneic bone marrow transplantation, non-T-cell depleted, UV-c, GVHD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Device: EUMATRON - EN 600 NT10 patients after allogeneic BMT (non T-depleted). |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients post non T cell depleted allogeneic stem cell transplantation
Key exclusion criteria (4 listed)
- morbidity unrelated to GVHD
- patients in an hemodynamic unstable condition
- acute uncontrolled bleeding
- patients undergoing dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUMATRON - EN 600 NTAlso: EN 600 NTfrequency - 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) | Device | I |
Primary outcome
safety and tolerability of UV-c phototherapy for the Prevention of Graft versus Host Disease after allogeneic stem cell transplantation
Time frame: 6 months
1 secondary outcome
monitoring immune system recovery, influence on survival rates, influence of stem cells origin on treatment & prevention of GVHD
Time frame: 100 days, 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reuven Or, MD principal investigator
Bone Marrow transplantation, cancer immunotherapy & immunobiology research center, Hadassah University Hospital, Ein - Kerem, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EUMATRON - EN 600 NT in people with Allogeneic Transplantation (Non T-cell Depleted), run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and tolerability of UV-c phototherapy for the Prevention of Graft versus Host Disease after allogeneic stem cell transplantation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2015.