Graft Versus Host DiseasePhase 2NCT00824954
Extracorporeal Photopheresis in Children and Young Adults With Refractory Acute Graft Versus Host Disease
A Phase 2 study testing ECP (performed on Themos UVAR-XTS or external UVA irradiator after cell collection by apheresis) in people with Graft Versus Host Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Purpose : to evaluate the efficacy of ECP in children with refractory acute GVHD This study addresses patients with persistent GVHD after steroid and/or monoclonal antibody therapy Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Graft Versus Host Disease
- What is being tested?
- ECP (performed on Themos UVAR-XTS or external UVA irradiator after cell collection by apheresis)
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Dec 2012
- Phase
- Phase 2
- 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 Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 0 to 30 years
- Acute GVHD refractory to steroids (disease progression after 2 days or absence of response after 4 days) and/or second line therapy (absence of response after 8 days)
- patient consent and/or parent consent
Who cannot join
- less of 10 kgs BW
- clinical or biological state precluding the apheresis
- previous GVHD therapy with anti-lymphocyte serum (excepted in the conditioning regimen)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Patrick Lacarin, 0473751195, placarin@chu-clermontferrand.fr
About this study
Official title: Evaluation of Extracorporeal Photochemotherapy in Children and Young Adults With Refractory Acute Graft Versus Host Disease After Allogeneic Stem Cell Transplantation
Purpose : to evaluate the efficacy of ECP in children with refractory acute GVHD This study addresses patients with persistent GVHD after steroid and/or monoclonal antibody therapy
Read the detailed description
One arm. Six sessions in two weeks. Classification in complete response (resolution of all signs of GVHD), partial response (improvement of at least one grade) or absence of response (Glucksberg criteria). Tapering depending on patient condition during weeks 2 to 10. Final evaluation at week 10. Steroid therapy tapering at the discretion of the investigator.
- Conditions
- Graft Versus Host Disease
- Being tested
- ECP (performed on Themos UVAR-XTS or external UVA irradiator after cell collection by apheresis)
- Keywords
- 0 to 30 years, Refractory Acute GVHD
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECP (performed on Themos UVAR-XTS or external UVA irradiator after cell collection by apheresis)Procedure or surgery
ECP (performed on Thermos UVAR-XTS or external UVA irradiator after cell collection by apheresis)
What is being measured
The primary outcome is the main question the study is designed to answer.
GVHD grading
Measured: during weeks 2 to 10
Secondary outcomes (1)
Overall survival Incidence of chronic GVHD
Measured: during weeks 2 to 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Etienne Merlin, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824954
- Sponsor's protocol ID
- CHU-0043
- Status last verified
- Jan 2011
- First submitted
- 18 Dec 2008
- Last updated
- 19 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Extracorporeal Photochemotherapy in Children and Young Adults With Refractory Acute Graft Versus Host Disease After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00824954
- Acronym / sponsor ID
- CHU-0043
- Conditions
- Graft Versus Host Disease
- Keywords
- 0 to 30 years, Refractory Acute GVHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 19 Jan 2009 (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.
Purpose : to evaluate the efficacy of ECP in children with refractory acute GVHD This study addresses patients with persistent GVHD after steroid and/or monoclonal antibody therapy
Detailed description
One arm. Six sessions in two weeks. Classification in complete response (resolution of all signs of GVHD), partial response (improvement of at least one grade) or absence of response (Glucksberg criteria). Tapering depending on patient condition during weeks 2 to 10. Final evaluation at week 10. Steroid therapy tapering at the discretion of the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 0 to 30 years
- Acute GVHD refractory to steroids (disease progression after 2 days or absence of response after 4 days) and/or second line therapy (absence of response after 8 days)
- patient consent and/or parent consent
Key exclusion criteria (3 listed)
- less of 10 kgs BW
- clinical or biological state precluding the apheresis
- previous GVHD therapy with anti-lymphocyte serum (excepted in the conditioning regimen)
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 |
|---|---|---|
| ECP (performed on Themos UVAR-XTS or external UVA irradiator after cell collection by apheresis)ECP (performed on Thermos UVAR-XTS or external UVA irradiator after cell collection by apheresis) | Procedure or surgery | – |
Primary outcome
GVHD grading
Time frame: during weeks 2 to 10
1 secondary outcome
Overall survival Incidence of chronic GVHD
Time frame: during weeks 2 to 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2011.
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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.
Etienne Merlin principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ECP (performed on Themos UVAR-XTS or external UVA irradiator after cell collection by apheresis) in people with Graft Versus Host Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Jan 2011. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Lacarin (04.73.75.11.95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GVHD grading (time frame: during weeks 2 to 10). 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 19 Jan 2011.