MORPHEE : Mechanisms of Cell Death Induced by Extracorporeal Photochemotherapy (MORPHEE)
Primary Purpose
Cutaneous T-Cell Lymphoma, Graft Vs Host Disease, Graft Rejection
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Samples collection
Sponsored by
About this trial
This is an interventional basic science trial for Cutaneous T-Cell Lymphoma focused on measuring Cell death, Extracorporeal Photochemotherapy
Eligibility Criteria
Inclusion Criteria:
- Adult patients
- Treated with ECP for at least 1 month, for control of GVHD in hematopoietic cell allograft (acute or chronic GVHD), treatment and control of cellular or humoral rejection in solid organ transplantation (heart, lung, kidney) or in the treatment of cutaneous T-cell lymphoma
Exclusion Criteria:
- Subjects with limited legal capacity.
- Subjects judged by the investigator to be unlikely to comply with study procedures
- Subjects with no social security coverage.
- Pregnant women.
- Subjects still in the exclusion period of another study, or according to the national registry of clinical trial participants.
Sites / Locations
- Centre Hospitalier Universitaire de BesançonRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients undergoing extracorporeal photochemotherapy
Arm Description
Outcomes
Primary Outcome Measures
Type of cell death induced by 8-MOP sensitization and UVA irradiation
Caspase-3 activation in Western blot
Type of cell death induced by 8-MOP sensitization and UVA irradiation
Gasdermin D cleavage in Western blot
Type of cell death induced by 8-MOP sensitization and UVA irradiation
MLKL (mixed lineage kinase domain-like pseudokinase) phosphorylation in Western blot
Secondary Outcome Measures
Full Information
NCT ID
NCT05333367
First Posted
April 4, 2022
Last Updated
May 31, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT05333367
Brief Title
MORPHEE : Mechanisms of Cell Death Induced by Extracorporeal Photochemotherapy
Acronym
MORPHEE
Official Title
MORPHEE : Mechanisms of Cell Death Induced by Extracorporeal Photochemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to describe the type of cell death induced by extracorporeal photochemotherapy, depending on the cell type, using a panel of complementary analysis techniques.
Detailed Description
Extracorporeal photochemotherapy (ECP) is a cell therapy used for its immunomodulation and tolerance induction capabilities. Its main indications are the control of graft-versus-host (GVH) disease in hematopoietic cell allografts, treatment and control of rejection in solid organ transplantation and the treatment of cutaneous T-cell lymphoma. Data on the mechanisms of action of ECP remains very patchy. This lack of data limits the discussion on therapeutic regimens by disease.
ECP consists of repeated apheresis sessions to collect leukocytes from the patient. The cells are then photosensitized, irradiated with UVA and reinjected into the patient in a closed circuit. In the context of GVH, induced cell death would stimulate the expansion of regulatory cells (Treg), restore a Th1/Th2 balance and decrease Th17 polarization. The ECP also allows the expansion of Treg in solid organ transplantation. Conversely, ECP would restore or activate an antitumor immune response in cutaneous T lymphoma.
The type of cells collected and treated would play a major role in the effects obtained. However, these hypotheses must be consolidated, in particular by detailing the initial role of cell death. Several questions remain, on the chronology of cell death in the different treated subpopulations, on the uptake by phagocytes, but especially on the type of cell death induced according to the cell type (necroptosis, apoptosis, pyroptosis, autophagy). The data generated will allow for validation or detail of the mechanisms of resolution of the inflammation and/or the anti-tumour effect observed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous T-Cell Lymphoma, Graft Vs Host Disease, Graft Rejection
Keywords
Cell death, Extracorporeal Photochemotherapy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients undergoing extracorporeal photochemotherapy
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Samples collection
Intervention Description
Sampling of 2 samples on the extracorporeal photochemotherapy circuit, before and after sensitization with 8-MOP and UVA irradiation (without additional puncture)
Primary Outcome Measure Information:
Title
Type of cell death induced by 8-MOP sensitization and UVA irradiation
Description
Caspase-3 activation in Western blot
Time Frame
24 hours
Title
Type of cell death induced by 8-MOP sensitization and UVA irradiation
Description
Gasdermin D cleavage in Western blot
Time Frame
24 hours
Title
Type of cell death induced by 8-MOP sensitization and UVA irradiation
Description
MLKL (mixed lineage kinase domain-like pseudokinase) phosphorylation in Western blot
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients
Treated with ECP for at least 1 month, for control of GVHD in hematopoietic cell allograft (acute or chronic GVHD), treatment and control of cellular or humoral rejection in solid organ transplantation (heart, lung, kidney) or in the treatment of cutaneous T-cell lymphoma
Exclusion Criteria:
Subjects with limited legal capacity.
Subjects judged by the investigator to be unlikely to comply with study procedures
Subjects with no social security coverage.
Pregnant women.
Subjects still in the exclusion period of another study, or according to the national registry of clinical trial participants.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charline VAUCHY, PhD
Phone
+33381218875
Email
cvauchy@chu-besancon.fr
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charline Vauchy, PhD
Email
cvauchy@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Thomas CREPIN, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MORPHEE : Mechanisms of Cell Death Induced by Extracorporeal Photochemotherapy
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