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

  • STATUS
    Recruiting
  • End date
    Sep 21, 2023
  • participants needed
    100
  • sponsor
    Jules Bordet Institute
Updated on 21 January 2021

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 transplantation or after donor lymphocyte infusion.

Details
Condition Refractory Chronic Graft Versus Host Disease (cGVHD), Refractory Chronic Graft Versus Host Disease (cGVHD)
Treatment Photopheresis Theraflex ECP™
Clinical Study IdentifierNCT03083574
SponsorJules Bordet Institute
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

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
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