Acute-graft-versus-host DiseasePhase 2PCE-aGVHDNCT03605940
A Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporal Photopheresis (ECP) as First-line Treatment of Standard II Acute Graft-versus-host Disease
A Phase 2 study testing Methoxsalen + ECP device and Corticosteroids in people with Acute-graft-versus-host Disease, run by Central Hospital, Nancy, France.
Trial summary
Acute graft versus host-disease remains a major cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation. The incidence of grade II to IV acute GVHD ranges from 30 to 50% of the patients transplanted. Steroids remain the standard first line treatment for acute GVHD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute-graft-versus-host Disease
- What is being tested?
- Methoxsalen + ECP device and Corticosteroids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 1 Apr 2022
- 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 ;
- Having received an allogeneic stem cell transplantation for any malignant or non-malignant hemopathy and whatever the type of donor and graft.
- with grade II acute GVHD with skin involvement (stage 1-3 skin +/- stage 1 gastro intestinal) in the 3 months following the allogeneic stem cell transplantation
- acute GVHD in the first line treatment
- validation of the presence of peripheral or central venous access allowing to perform 2 ECP per week during 3 months. In the absence of a pre-existing and adpated central catheter at the time of inclusion, peripheral venous access will be preferred
- Leucocytes > 1.5 G/L
Show all 9Show fewer
- Platelets > 30 G/L, Haematocrite > 27% (allowed transfusions)
- Patient affiliated to a French Social Security regimen
- information consent form signed.
Who cannot join
- acute GVHD of grade I
- acute GVHD of grade > II
- progressive hematologic disease at inclusion
- uncontrolled ongoing infection at time of inclusion: bacterial or fungal infections, increasing CMV viral load.
- patient with HIV positivity or replicative HBV or HCV infection
- Contraindications for UVADEX / photopheresis / stéroids / posaconazole / heparin
Show all 9Show fewer
- Patient with a history of deep venous thrombosis
- Pregnancy
- Women of child bearing potentiel not using contaception
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-center Randomized Phase II Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporal Photopheresis (ECP) as First-line Treatment of Standard Risk Grade II Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
Acute graft versus host-disease remains a major cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation. The incidence of grade II to IV acute GVHD ranges from 30 to 50% of the patients transplanted. Steroids remain the standard first line treatment for acute GVHD.
Prolonged exposure to steroids is associated to increased risk of infections and of osteoporosis, osteonecrosis and alteration of growth in children. Thus, reducing steroid exposure in order to reduce treatment-related morbidity is another important goal in the management of standard risk aGVHD.
Read more
Extracoporeal photopheresis (ECP) is active in controlling steroid refractory or dependent acute GVHD.
Hypothesis:
In this study, the team hypothesizes that addition of ECP to first line treatment with 2 mg/kg steroids of standard risk grade II aGVHD can reduce steroid exposure by increasing the probability of 6 month FFTF including absence of systemic steroids for chronic GVHD.
- Conditions
- Acute-graft-versus-host Disease
- Being tested
- Methoxsalen + ECP device, Corticosteroids
- Keywords
- Acute-graft-versus-host Disease, Extracorporal Photopheresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methoxsalen + ECP deviceCombination product
2 sessions per week during 4 weeks and 1 session per week during 8 weeks
CorticosteroidsDrug
2 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | corticosteroids + ECP Receives: Combination Product: Methoxsalen + ECP device; Drug: Corticosteroids |
| Contrôl group | Active comparator | corticosteroids alone Receives: Drug: Corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of being free of treatment failure (probability of survival without relapse, additional line of treatment for aGVHD and systemic therapy for chronic GVHD)
Measured: 6 months
Secondary outcomes (16)
mean of the cumulative dose of steroids
Measured: Month 1- Month 2 - Month 3 - Month 6 - Month 12
cumulative incidence rate of infections
Measured: Month 6 - Month 12
cumulative incidence of thromboembolic complications
Measured: Month 3
incidence of chronic GVHD
Measured: Month 6 - Month 12
severity of chronic GVHD
Measured: Month 6 - Month 12
incidence rate of non-relapse mortality
Measured: Month 6 - Month 12
incidence of disease relapse
Measured: Month 6 - Month 12
disease-free survival
Measured: Month 6 - Month 12
overall survival
Measured: Month 6 - Month 12
scores of health-related quality of life using the French validated FACT-BMT
Measured: Month 3 - Month 6 - Month 12
Total T cells number
Measured: Month 3 - Month 6 - Month 12
CD4 T cells number
Measured: Month 3 - Month 6 - Month 12
CD8 T cells number
Measured: Month 3 - Month 6 - Month 12
B cells number
Measured: Month 3 - Month 6 - Month 12
NK cells number
Measured: Month 3 - Month 6 - Month 12
gamma globulin number
Measured: Month 3 - Month 6 - Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Oct 2018 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-graft-versus-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
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605940
- Sponsor's protocol ID
- 2017-005162-22
- Other IDs
- PSS2017/PCE-aGVHD-RUBIO/VS, 2017
- Acronym
- PCE-aGVHD
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. 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 Extracorporal Photopheresis (ECP) as First-line Treatment of Standard Risk Grade II Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03605940
- Acronym / sponsor ID
- PCE-aGVHD / 2017-005162-22
- Conditions
- Acute-graft-versus-host Disease
- Keywords
- Acute-graft-versus-host Disease, Extracorporal Photopheresis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 30 Jul 2018 (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.
Acute graft versus host-disease remains a major cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation. The incidence of grade II to IV acute GVHD ranges from 30 to 50% of the patients transplanted. Steroids remain the standard first line treatment for acute GVHD.
Prolonged exposure to steroids is associated to increased risk of infections and of osteoporosis, osteonecrosis and alteration of growth in children. Thus, reducing steroid exposure in order to reduce treatment-related morbidity is another important goal in the management of standard risk aGVHD.
Extracoporeal photopheresis (ECP) is active in controlling steroid refractory or dependent acute GVHD.
Hypothesis:
In this study, the team hypothesizes that addition of ECP to first line treatment with 2 mg/kg steroids of standard risk grade II aGVHD can reduce steroid exposure by increasing the probability of 6 month FFTF including absence of systemic steroids for chronic GVHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Combination Product: Methoxsalen + ECP device, Drug: Corticosteroidscorticosteroids + ECP |
| Contrôl group | Active comparator | Drug: Corticosteroidscorticosteroids alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years ;
- Having received an allogeneic stem cell transplantation for any malignant or non-malignant hemopathy and whatever the type of donor and graft.
- with grade II acute GVHD with skin involvement (stage 1-3 skin +/- stage 1 gastro intestinal) in the 3 months following the allogeneic stem cell transplantation
- acute GVHD in the first line treatment
- validation of the presence of peripheral or central venous access allowing to perform 2 ECP per week during 3 months. In the absence of a pre-existing and adpated central catheter at the time of inclusion, peripheral venous access will be preferred
Key exclusion criteria (9 listed)
- acute GVHD of grade I
- acute GVHD of grade > II
- progressive hematologic disease at inclusion
- uncontrolled ongoing infection at time of inclusion: bacterial or fungal infections, increasing CMV viral load.
- patient with HIV positivity or replicative HBV or HCV infection
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 |
|---|---|---|
| Methoxsalen + ECP device2 sessions per week during 4 weeks and 1 session per week during 8 weeks | Combination product | Experimental group |
| Corticosteroids2 mg/kg/day | Drug | Contrôl group, Experimental group |
Primary outcome
Probability of being free of treatment failure (probability of survival without relapse, additional line of treatment for aGVHD and systemic therapy for chronic GVHD)
Time frame: 6 months
16 secondary outcomes
mean of the cumulative dose of steroids
Time frame: Month 1- Month 2 - Month 3 - Month 6 - Month 12
cumulative incidence rate of infections
Time frame: Month 6 - Month 12
cumulative incidence of thromboembolic complications
Time frame: Month 3
incidence of chronic GVHD
Time frame: Month 6 - Month 12
severity of chronic GVHD
Time frame: Month 6 - Month 12
incidence rate of non-relapse mortality
Time frame: Month 6 - Month 12
incidence of disease relapse
Time frame: Month 6 - Month 12
disease-free survival
Time frame: Month 6 - Month 12
overall survival
Time frame: Month 6 - Month 12
scores of health-related quality of life using the French validated FACT-BMT
Time frame: Month 3 - Month 6 - Month 12
Total T cells number
Time frame: Month 3 - Month 6 - Month 12
CD4 T cells number
Time frame: Month 3 - Month 6 - Month 12
CD8 T cells number
Time frame: Month 3 - Month 6 - Month 12
B cells number
Time frame: Month 3 - Month 6 - Month 12
NK cells number
Time frame: Month 3 - Month 6 - Month 12
gamma globulin number
Time frame: Month 3 - Month 6 - Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methoxsalen + ECP device and Corticosteroids in people with Acute-graft-versus-host Disease, run by Central Hospital, Nancy, 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 9 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 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Marie-Thérèse RUBIO, PU-PH (0383153282, m.rubio@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of being free of treatment failure (probability of survival without relapse, additional line of treatment for aGVHD and systemic therapy for chronic GVHD) (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 30 Jul 2018.