NCT03361254: cryo-ECP

Cryopreservation of White Blood Cells Before Their UVA Irradiation for Graft Versus Host Disease Treatment

Status unknown NA Last updated 27 January 2020

What this trial tests

NA trial testing cryopreservation in Graft Versus Host Disease in 5 participants. Status unknown.

Timeline

31 March 2020

Primary endpoint
30 June 2020

30 September 2020

Quick facts

Lead sponsor	Central Hospital, Nancy, France
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	31 March 2020
Primary completion	30 June 2020
Estimated completion	30 September 2020

Drugs / interventions tested

• cryopreservation — full drug profile →

Conditions studied

• Graft Versus Host Disease — all drugs for Graft Versus Host Disease →

Sponsor

Central Hospital, Nancy, France

Who can join

18 and older, any sex, with Graft Versus Host Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.