Graft Versus Host Disease Clinical Trial
— cryo-ECPOfficial title:
Division and Cryopreservation of Autologous Blood Nuclear Cells for Intensive Regimen of Extracorporeal Photopheresis : Interest for the Treatment of Patients With Steroid Resistant Graft Versus Host Disease
Extracorporeal photopheresis (ECP) is a worldwide recognized treatment of acute and chronic
mild to moderate graft versus host disease (GVHD), in second or further line of treatment.
Contrary to immunosuppressive drugs, ECP is not associated with side effects such as
opportunistic infections, and is not associated with a higher frequency of relapse of the
initial hematological disease. High intensity of ECP regimen (1 to 3 sessions per week, in
case of chronic or acute GVHD) seems to be correlated to a higher efficacy. However, high
intensity of ECP treatment is often difficult to sustain, because of frequent logistical
problems to perform aphereses, such as venous access failure, infections of central line,
deep blood cytopenias that require many transfusions before performing aphereses. Merlin et
al. first described the feasibility of white blood cells cryopreservation before UVA
irradiation, in vitro, then in vivo. We also recently reported the feasibility and efficacy
of cryopreserved ECP in a series of 20 patients (adults and children), with acute and chronic
GVHD, who had recurrent contraindications to aphereses, that prevented the realization of an
intensive program of ECP. No adverse events occurred, and efficacy seemed to be similar to
"classical" ECP (35% of complete overall response, and 40% of partial response). White blood
cells (WBC) were divided after collection on Optia or Cellex apheresis machines: one was
immediately treated with 8-MOP (methoxsalen) and ultraviolet A (UVA) irradiation, while the
other was cryopreserved, and further (a few days later) thawed, sensitized with 8-MOP and
irradiated before injection to the patient.
The aim of this study is to analyze this method in a prospective way, with complete
biological data collection, of apoptosis, cytokines release etc…, necessary to the full
description of cryopreservation of white blood cells before their irradiation and reinjection
to the patient.
We will propose this technique of cryopreservation to every patient with an indication of ECP
for acute or chronic GVHD in Nancy Hospital for 18 months.
Status | Not yet recruiting |
Enrollment | 5 |
Est. completion date | September 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult or child who received an allogeneic hematopoietic stem cell transplantation, with a medical follow-up at the University Hospital of Nancy, or at the other University Hospitals in the great East region (Dijon, Reims, Besançon) in which ECP is not accessible. - Eligible for ECP for the treatment of acute or chronic steroid refractory GVHD, after pluridisciplinary concertations - Patients (or parents) who received full information on the research and who signed a consent for this research Non inclusion Criteria: - Children under 10 kg of weight - Patients or parents who did not sign a consent - Patients who present an absolute contra-indication for apheresis: recent pulmonary embolism, deep vein thrombosis, myocardial infarction, active and evolutive bacterial or fungal infection, hemodynamics instability, deep anemia (Hb < 8g/dl) or deep thrombocytopenia (< 20 g/L) despite transfusions, severe hypocalcemia. - Women in age to procreate without contraception |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | intensity of ECP regimen | Number of ECP (fresh and thawed) sessions during 3 months | 3 months after the first ECP session | |
Secondary | systemic infections during 3 months after cryo-ECP (safety) | at 6 weeks and 3 months after the first ECP session | ||
Secondary | occurrence of death after cryo-ECP (safety) | at 6 weeks and 3 months after the first ECP session | ||
Secondary | occurrence of relapse of the initial hematological disease after cryo-ECP (safety) | at 6 weeks and 3 months after the first ECP session | ||
Secondary | Steroid sparing effect (efficacy) | at 6 weeks and 3 months after the first ECP session | ||
Secondary | GVHD grade (severity) (efficacy) | at 6 weeks and 3 months after the first ECP session | ||
Secondary | immunosuppressive drugs used (efficacy) | at 6 weeks and 3 months after the first ECP session |
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