Graft Vs Host DiseasePhase 2COPAVEHDINCT06133192
Steroids Versus ECP and Steroids as First-line Treatment of Grade II Acute GVHD
A Phase 2 study testing Uvadex and Steroids in people with Graft Vs Host Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The goal of this clinical trial is to compare as a first line of grade II skin acute GVHD sconventional treatment with steroids alone to a combination of steroids and extracoporeal photopheresis (ECP) The primary end point will compare Freedom from treatment failure at 6 months from randomization as defined by meeting… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Vs Host Disease
- What is being tested?
- Uvadex and Steroids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2024to Jan 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years,
- allogeneic hematopoietic stem cell transplantation received (from any type of graft and donor) after malignant or non malignant disease
- patient suffering from Grade II acute GVHD with skin +/- high GI involvement (stage 2-3 skin + upper gastrointestinal tract or skin stage 3) in the 3 months following stem cell transplantation
- patient requiring first line treatment for acute GVHD
- patient able to start PCE therapy in the 3 days after randomization
- validation of the presence of a peripheral or central venous access (its type should be conform to the recommendations described in the Therakos Cellex operator manual), allowing to perform PCE sessions weekly during 3 months. In the absence of appropriate preexisting central line at inclusion, peripheral access will be preferred.
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- leukocytes > 1.5 G/l, platelets > 30 G/l, hematocrit > 27% (blood transfusion are permitted), based on the last available blood testing results,
- patient with French Health Insurance,
- patient informed about the clinical trial content and organization,
- informed consent form signed.
Who cannot join
- - Grade 1 acute GVHD,
- acute GVH grade > II or acute GVH with lower gastrointestinal tract or with liver involvement,
- relapse of the hematologic disease at time of acute GVHD,
- uncontrolled ongoing infection at time of inclusion: bacterial or fungal infections, CMV reactivation with increasing CMV viral load,
- HIV positivity or replicative HBV or HCV infection (based on pre-transplant assessment),
- patient with allergy or contraindications to UVADEX, extracorporeal photopheresis, steroids, or posaconazole (see details in the study protocol),
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- woman of childbearing age without efficient contraceptive method, pregnancy or breast feeding woman,
- patient with history of profound venous thrombosis in the last 5 years,
- patient included in another acute GVHD prospective clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center Randomized Phase II Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporeal Photopheresis as First-line Treatment of Grade II Acute Graft-versus-host Disease With Skin Involvement Occuring After Allogeneic Stem Cell Transplantation
The goal of this clinical trial is to compare as a first line of grade II skin acute GVHD sconventional treatment with steroids alone to a combination of steroids and extracoporeal photopheresis (ECP)
The primary end point will compare Freedom from treatment failure at 6 months from randomization as defined by meeting all the following 4 conditions:
- to be alive
- without relapse of the hematological disease
- without having required a new line of treatment for acute GVHD
- without initiating a systemic treatment for chronic GVHD.
Read the detailed description
A multi-center randomized phase II study comparing corticosteroids alone (standard of care) versus corticosteroids and extracorporeal photopheresis as first-line treatment of Grade II acute graft-versus-host disease with skin +/- upper gastrointestinal involvement occurring after allogeneic stem cell transplantation
Corticosteroids will be started at 2 mg/kg in both arms and will be tapered once acute GVHD achieves complete remission according to strict protocol guidelines (-20% of the daily dose per week until 1 mg/kg and then 10 mg twice a day in order to stop steroids within 2 to 3 months from randomization).
Extracorporeal Photopheresis (ECP) will be performed in the experimental arm : 2 sessions/week during 4 weeks then 1 session/week during 8 weeks), i.e. a total of 16 ECP sessions in 12 weeks.
- Conditions
- Graft Vs Host Disease
- Being tested
- Uvadex, Steroids
- 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.
UvadexDrug
Uvadex use for ECP
SteroidsDrug
steroids 2 mg/kg/d
| Study group | Role | What they receive |
|---|---|---|
| Steroids alone | Active comparator | Steroids 2 mg/kg/day Receives: Drug: Steroids |
| ECP + steroids | Experimental | Steroids 2 mg/kg abd ECP x 2 per week for 1 months and once a week for 2 months Receives: Drug: Uvadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from treatment failure
To be alive, without disease relapse, without second line treatment for acute GVHD and without systemic treatment for chronic GVHD
Measured: at 6 months from randomization
Secondary outcomes (6)
steroid cumulative dose
cumulative dose of steroids over time
Measured: at 6 months from randomization
infections
incidence rate of infections (bacteremia, septicemia, fungal infections, parasite and virus
Measured: at 6 months from randomization
chronic GVHD
incidence and severity of chronic GVHD
Measured: at 12 months from randomization
non-relapse mortality
non-relapse mortality rate
Measured: at 12 months from randomization
relapse
incidence of disease relapse
Measured: at 12 months from randomization
overall survival
overall survival logrank
Measured: at 12 months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study startJan 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Thérèse RUBIO, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133192
- Sponsor's protocol ID
- 2023-508614-41-00
- Other IDs
- 2023
- Acronym
- COPAVEHDI
- Status last verified
- Oct 2023
- First submitted
- 10 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Randomized Phase II Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporeal Photopheresis as First-line Treatment of Grade II Acute Graft-versus-host Disease With Skin Involvement Occuring After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06133192
- Acronym / sponsor ID
- COPAVEHDI / 2023-508614-41-00
- Conditions
- Graft Vs Host Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 15 Nov 2023 (actual)
- 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 goal of this clinical trial is to compare as a first line of grade II skin acute GVHD sconventional treatment with steroids alone to a combination of steroids and extracoporeal photopheresis (ECP)
The primary end point will compare Freedom from treatment failure at 6 months from randomization as defined by meeting all the following 4 conditions:
- to be alive
- without relapse of the hematological disease
- without having required a new line of treatment for acute GVHD
- without initiating a systemic treatment for chronic GVHD.
Detailed description
A multi-center randomized phase II study comparing corticosteroids alone (standard of care) versus corticosteroids and extracorporeal photopheresis as first-line treatment of Grade II acute graft-versus-host disease with skin +/- upper gastrointestinal involvement occurring after allogeneic stem cell transplantation
Corticosteroids will be started at 2 mg/kg in both arms and will be tapered once acute GVHD achieves complete remission according to strict protocol guidelines (-20% of the daily dose per week until 1 mg/kg and then 10 mg twice a day in order to stop steroids within 2 to 3 months from randomization).
Extracorporeal Photopheresis (ECP) will be performed in the experimental arm : 2 sessions/week during 4 weeks then 1 session/week during 8 weeks), i.e. a total of 16 ECP sessions in 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroids alone | Active comparator | Drug: SteroidsSteroids 2 mg/kg/day |
| ECP + steroids | Experimental | Drug: UvadexSteroids 2 mg/kg abd ECP x 2 per week for 1 months and once a week for 2 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 18 years,
- allogeneic hematopoietic stem cell transplantation received (from any type of graft and donor) after malignant or non malignant disease
- patient suffering from Grade II acute GVHD with skin +/- high GI involvement (stage 2-3 skin + upper gastrointestinal tract or skin stage 3) in the 3 months following stem cell transplantation
- patient requiring first line treatment for acute GVHD
- patient able to start PCE therapy in the 3 days after randomization
Key exclusion criteria (9 listed)
- - Grade 1 acute GVHD,
- acute GVH grade > II or acute GVH with lower gastrointestinal tract or with liver involvement,
- relapse of the hematologic disease at time of acute GVHD,
- uncontrolled ongoing infection at time of inclusion: bacterial or fungal infections, CMV reactivation with increasing CMV viral load,
- HIV positivity or replicative HBV or HCV infection (based on pre-transplant assessment),
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 |
|---|---|---|
| UvadexUvadex use for ECP | Drug | ECP + steroids |
| Steroidssteroids 2 mg/kg/d | Drug | Steroids alone |
Primary outcome
Freedom from treatment failure
Time frame: at 6 months from randomization
To be alive, without disease relapse, without second line treatment for acute GVHD and without systemic treatment for chronic GVHD
6 secondary outcomes
steroid cumulative dose
Time frame: at 6 months from randomization
infections
Time frame: at 6 months from randomization
chronic GVHD
Time frame: at 12 months from randomization
non-relapse mortality
Time frame: at 12 months from randomization
relapse
Time frame: at 12 months from randomization
overall survival
Time frame: at 12 months from randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Uvadex and Steroids in people with Graft Vs Host Disease, run by Central Hospital, Nancy, France 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 10 inclusion and 9 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 15 Nov 2023. 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?
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?
Freedom from treatment failure (time frame: at 6 months from randomization). 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 15 Nov 2023.