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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
CHU Liège
Liège, Liège, Belgium
RECRUITINGZiekenhuis Netwerk Antwerpen
Antwerp, Belgium
RECRUITINGAZ Sint-Jan Brugge
Bruges, Belgium
Response rates of chronic GVHD to the Theraflex ECP treatment.
Percentage of patients reaching complete response, percentage of patients reaching partial response.
Time frame: During the study (8 years and 2months)
Duration of response.
Time from achieving at least a partial response to the time of progression.
Time frame: During the study (8 years and 2months)
GVHD-partial response survival.
Time from partial response to either the first progression of GVHD or the date of death, whichever occurs first.
Time frame: During the study (8 years and 2months)
GVHD-free Interval.
Interval from the date of complete response to the date of the first progression of GVHD.
Time frame: During the study (8 years and 2months)
GVHD-free survival.
Time fromcomplete response to either the first progression of GVHD or the date of death, whichever occurs first.
Time frame: During the study (8 years and 2months)
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)
Time frame: During the study (8 years and 2months)
Discontinuation of immunosuppressive drugs during the ECP treatment
Time frame: During the study (8 years and 2months)
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Institut Jules Bordet
Brussels, Belgium
RECRUITINGUniversitair Ziekenhuis Antwerpen
Edegem, Belgium
RECRUITINGUniversitair Ziekenhuis Gent
Ghent, Belgium
NOT_YET_RECRUITINGUniversitair Ziekenhuis Brussel
Jette, Belgium
RECRUITINGCliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
RECRUITINGOccurrence of adverse events and serious adverse events related to extracorporeal photopheresis.
Time frame: During the study (1 year of follow up after the last treatment)
Incidence of viral, bacterial, fungal and parasitic infections
Time frame: During the study (8 years and 2months)