AzTrials
AzTrials

Refractory Chronic Graft Versus Host Disease (cGVHD)Phase 2NCT03083574

Extracorporeal Photopheresis Using Theraflex ECP™ for Patients With Refractory Chronic Graft Versus Host Disease (cGVHD)

A Phase 2 study testing Photopheresis Theraflex ECP™ in people with Refractory Chronic Graft Versus Host Disease (cGVHD), run by Jules Bordet Institute at 8 sites in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The present project is a prospective, multicenter, non-randomized, phase II trial which aims to evaluate the clinical impact and the safety of extracorporeal photopheresis (ECP) using the Theraflex system in patients with refractory chronic graft versus host disease (cGVHD) after any type of hematopoietic stem cell… Read more about this study

Who is it for?
Any age
What is being tested?
Photopheresis Theraflex ECP™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
8 sitesBelgium
Study dates
Sep 2014to Sep 2023
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients must have chronic GVHD (cGVHD) occurring after any type of HSC transplantation : with any type of donor (HLA-identical siblings or HLA-matched or mismatched family or unrelated donor); with any type of conditioning (full-intensity, reduced-intensity, nonmyeloablative, no conditioning); with any type of HSC (bone marrow, PBSC, cord blood) or after donor lymphocyte infusion.
  • Patients must have cGVHD primarily affecting at least one of the following organs: skin; oral mucosal; eye; liver; lung; joints; fascia. Gastro-intetinal (GI) cGVHD alone is not a sufficient inclusion criterion.
  • Patients must have cGVHD that has already been treated with first-line systemic therapy for at least 1 month at effective doses. First-line systemic therapy must have included at least prednisolone 1 mg/kg/day or equivalent. In case of formal contraindication to steroid therapy, first-line systemic therapy must have included therapeutic doses of at least one of the following drugs: tacrolimus or ciclosporine (if patient not treated with a calcineurin inhibitor at onset of cGVHD), sirolimus, everolimus, mycophenolate mofetyl.
  • Patients must require further salvage therapy for cGVHD because of either refractoriness or contraindication/intolerance to current therapy.
  • Need for salvage therapy is defined by any of the following criteria :
  • the development of 1 or more new sites of disease while being treated for chronic GVHD
Show all 14Show fewer
  • progression of existing sites of disease while receiving treatment for chronic GVHD
  • failure to improve despite at least 1 month of standard treatment for chronic GVHD,
  • relapse/progression of cGVHD while tapering current treatment for cGVHD.
  • Patients may have received any number of previous lines of treatment for cGVHD.
  • Concomitant treatment with other immunosuppressors is allowed if they were started and maintained at constant dosage for at least one month before the start of ECP. Shorter delay can be accepted for patients with highly progressive GVHD requiring salvage therapy.
  • Signed informed consent.
  • Any age.
  • Weight > 15 Kg (because of leukapheresis). Weight <15 Kg is acceptable if a suitable method of leukapheresis has been developed and approved at site.

Who cannot join

  • Patient has received any investigational agent for chronic GVHD in the past 4 weeks.
  • Patient has started a new line of systemic therapy for cGVHD in the past 4 weeks. Shorter delay can be accepted for patients with highly progressive GVHD requiring salvage therapy.
  • Known sensitivity to psoralen compounds such as 8-methoxypsoralen
  • Comorbidities that may result in photosensitivity (coexisting skin cancer or photosensitive disease (such as porphyria, lupus, albinism…)
  • Aphakia. MOP is contraindicated in patients with aphakia, because of the significantly increased risk of retinal damage due to the absence of lenses
  • Known allergy to one of the components used in apheresis (e.g., heparin and citrate).
Show all 19Show fewer
  • History of heparin-induced thrombocytopenia or patients with serious coagulation disorders.
  • Unable to tolerate the apheresis procedure including extracorporeal volume shifts because of uncompensated congestive heart failure, pulmonary edema, severe lung disease, severe renal failure, hepatic encephalopathy, or any other reason.
  • Bilirubin > 25 mg/L.
  • Absolute neutrophil count < 1.0 x 109 / L despite use of growth factors
  • Platelet count < 20 x 109 / L despite platelet transfusion
  • HIV seropositivity.
  • Uncontrolled infection
  • Relapse or progression of the hematological malignancy.
  • Eastern Cooperative Oncology Group (ECOG) score > 2.
  • Pregnancy or breastfeeding
  • Patient is a fertile man or woman who is unwilling to use contraceptive techniques during and for 12 months following treatment.
  • Any serious illness with expected survival less than 6 months.
  • Any clinically significant medical or other condition that in the investigator's opinion could interfere with the administration of photopheresis or interpretation of study results, or compromise the safety or wellbeing of the patient.

Trial locations and contacts

8 sites in 1 country.

Philippe Lewalle, MD, PhD contact

32-2-5417208

philippe.lewalle@bordet.be

8 sites in 1 country

Belgium8 sites, 8 recruiting

  • Ziekenhuis Netwerk Antwerpen

    Antwerp, 2060

    Pierre Zachee, MD, PhD, 32-3-2177111, pierre.zachee@zna.be

    Pierre Zachee, MD, PhD

    Recruiting

  • AZ Sint-Jan Brugge

    Bruges, 8000

    Dominik Selleslag, MD, 32-50-453060, dominik.selleslag@azbrugge.be

    Tom Lodewyck, MD, 32-50-453060, tom.lodewyck@azbrugge.be

    Recruiting

  • Institut Jules Bordet

    Brussels, 1000

    Philippe Lewalle, MD, PhD, 32-2-5417208, philippe.lewalle@bordet.be

    Philippe Lewalle, MD, PhD

    Recruiting

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

    Zwi Berneman, MD, PhD, 32-3-2204111, zwi.berneman@uza.be

    Zwi Berneman, MD, PhD

    Recruiting

  • Universitair Ziekenhuis Gent

    Ghent, 8000

    Lucien Noens, MD, PhD, 32-9-3323464, Lucien.Noens@Ugent.be

    Tessa Kerre, MD, PhD, 32-9-3323464, Tessa.Kerre@Ugent.be

    Not yet recruiting

  • Universitair Ziekenhuis Brussel

    Jette, 1090

    Rik Schots, MD, PhD, 32-2-4763105, Rik.Schots@uzbrussel.be

    Ann De Becker, MD, 32-2-4763105, Ann.Debecker@uzbrussel.be

    Recruiting

  • CHU Liège

    Liège, Liège, 4000

    Yves Beguin, MD, PhD, 32-4-3667201, yves.beguin@chu.ulg.ac.be

    Frédéric Baron, MD, PhD, 32-4-3667201, F.Baron@ulg.ac.be

    Recruiting

  • Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert, 1200

    Xavier Poiré, MD, 32-2-7641809, Xavier.Poire@uclouvain.be

    Xavier Poiré, MD

    Recruiting

Other trials in Belgium

About this study

Official title: A Phase II Study to Assess the Safety and the Efficacy of Extracorporeal Photopheresis Using the Theraflex ECP™ for Patients With Refractory Chronic Graft Versus Host Disease (cGVHD)

The present project is a prospective, multicenter, non-randomized, phase II trial which aims to evaluate the clinical impact and the safety of extracorporeal photopheresis (ECP) using the Theraflex system in patients with refractory chronic graft versus host disease (cGVHD) after any type of hematopoietic stem cell transplantation or after donor lymphocyte infusion.

Being tested
Photopheresis Theraflex ECP™
Keywords
Hematology, Chronic graft versus host disease (cGVHD), Extracorporeal photopheresis, Hematopoietic stem cell transplantation, Donor lymphocyte infusion
Medical subject headings
Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Photopheresis Theraflex ECP™Device

    The Macopharma (Theraflex ECP™) approach is based on a multistep procedure involving (1) standard mononuclear cell apheresis, (2) injection of the 8-Mop in the apheresis bag, (3) UVA exposure of the bag in the Macogenic illumination device, and (4) reinfusion of the cells into the patients.

Study groups in NCT03083574
Study groupRoleWhat they receive
Photopheresis Theraflex ECP™ExperimentalAll patients will initially be treated by 6 cycles of extracorporeal photopheresis (i.e. extracorporeal photopheresis on two consecutive days) administered every 2 weeks. Patients will then be evaluated after 3 months and treatment continuation will be decided based on response.
Receives: Device: Photopheresis Theraflex ECP™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rates of chronic GVHD to the Theraflex ECP treatment.

    Percentage of patients reaching complete response, percentage of patients reaching partial response.

    Measured: During the study (8 years and 2months)

  2. Duration of response.

    Time from achieving at least a partial response to the time of progression.

    Measured: During the study (8 years and 2months)

  3. GVHD-partial response survival.

    Time from partial response to either the first progression of GVHD or the date of death, whichever occurs first.

    Measured: During the study (8 years and 2months)

  4. GVHD-free Interval.

    Interval from the date of complete response to the date of the first progression of GVHD.

    Measured: During the study (8 years and 2months)

  5. GVHD-free survival.

    Time fromcomplete response to either the first progression of GVHD or the date of death, whichever occurs first.

    Measured: During the study (8 years and 2months)

Secondary outcomes (4)

  1. Percentage of steroid dose saving.

    Percentage of dose reduction from the date of first ECP to the lowest dose of steroids taken by the patient during a minimum of 3 months (except in case of dose reduction due to adverse events related to steroids)

    Measured: During the study (8 years and 2months)

  2. Discontinuation of immunosuppressive drugs during the ECP treatment

    Measured: During the study (8 years and 2months)

  3. Occurrence of adverse events and serious adverse events related to extracorporeal photopheresis.

    Measured: During the study (1 year of follow up after the last treatment)

  4. Incidence of viral, bacterial, fungal and parasitic infections

    Measured: During the study (8 years and 2months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2017
  2. Study startSep 2014
  3. Primary completionSep 2022 (estimated)
  4. Study completionSep 2023 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03083574
Sponsor's protocol ID
BHS-TC-11
Status last verified
Mar 2017
First submitted
14 Jan 2015
Last updated
20 Mar 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Photopheresis Theraflex ECP™ in people with Refractory Chronic Graft Versus Host Disease (cGVHD), run by Jules Bordet Institute at 8 sites in Belgium.

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 14 inclusion and 19 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 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Belgium. 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 Philippe Lewalle, MD, PhD (32-2-5417208, philippe.lewalle@bordet.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rates of chronic GVHD to the Theraflex ECP treatment. (time frame: During the study (8 years and 2months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03083574.

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 20 Mar 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in