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

NCT03361254 | Unknown

• 1 other identifier: APJC2015/CRYOPCE-POCHON/NK
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Graft Versus Host Disease

Outcome Measures

Primary Outcomes (1)

• intensity of ECP regimen

  Number of ECP (fresh and thawed) sessions during 3 months

  3 months after the first ECP session

Secondary Outcomes (6)

• systemic infections during 3 months after cryo-ECP (safety)

  at 6 weeks and 3 months after the first ECP session

• occurrence of death after cryo-ECP (safety)

  at 6 weeks and 3 months after the first ECP session

• occurrence of relapse of the initial hematological disease after cryo-ECP (safety)

  at 6 weeks and 3 months after the first ECP session

• Steroid sparing effect (efficacy)

  at 6 weeks and 3 months after the first ECP session

• GVHD grade (severity) (efficacy)

  at 6 weeks and 3 months after the first ECP session

Interventions

cryopreservation BIOLOGICAL

cryopreservation to every patient with an indication of ECP for acute or chronic GVHD in Nancy Hospital for 18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Cryopreservation

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques

Central Study Contacts

Cécile POCHON, Dr.

CONTACT

00 33 3 83 15 46 28; c.pochon@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: demonstrate the ability of this technique to follow high intensity regimen recommendations

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 4, 2017
• Study Start: March 31, 2020
• Primary Completion: June 30, 2020
• Study Completion: September 30, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01