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Recruiting NCT05333367

MORPHEE : Mechanisms of Cell Death Induced by Extracorporeal Photochemotherapy

No phase Interventional Cutaneous T-Cell Lymphoma Graft Vs Host Disease Graft Rejection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Samples collection.
Who it may be relevant to
Registry conditions: Cutaneous T-Cell Lymphoma, Graft Vs Host Disease, Graft Rejection. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Other Samples collection
    Sampling of 2 samples on the extracorporeal photochemotherapy circuit, before and after sensitization with 8-MOP and UVA irradiation (without additional puncture)

Primary outcome measures

  • Type of cell death induced by 8-MOP sensitization and UVA irradiation [Time frame: 24 hours]
  • Type of cell death induced by 8-MOP sensitization and UVA irradiation [Time frame: 24 hours]
  • Type of cell death induced by 8-MOP sensitization and UVA irradiation [Time frame: 24 hours]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • Centre Hospitalier Universitaire de Besançon — Besançon

Identifiers

NCT: NCT05333367 · 2022/679

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗