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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2023-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Extracorporeal Photopheresis (ECP) With Methoxsalen for Chronic Graft Versus Host Disease (cGVHD)

NCT01380535

Chronic Graft Versus Host Disease

COMPLETED EARLY_PHASE1

Theralux Extracorporeal Photochemotherapy (ECP) in Patients With Extensive Chronic Graft Versus Host Disease (GvHD)

NCT00248365

Graft vs Host Disease

COMPLETED PHASE1/PHASE2

Extracorporeal Photopheresis in Children and Young Adults With Refractory Acute Graft Versus Host Disease

NCT00824954

Graft Versus Host Disease

UNKNOWN PHASE2

ECP Combination Study

NCT05052385

Steroid Refractory GVHD

COMPLETED

Extracorporeal Photopheresis to Treat Chronic Graft-Versus-Host Disease

NCT00048789

Graft vs Host Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Refractory Chronic Graft Versus Host Disease (cGVHD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Photopheresis Theraflex ECP™

All 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.

Group Type EXPERIMENTAL

Photopheresis Theraflex ECP™

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Photopheresis Theraflex ECP™

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
* 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.

Exclusion Criteria

* 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).
* 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No