Modification of Extracorporeal Photopheresis in Cutaneous T-cell Lymphoma or Chronic Graft-versus-host Disease
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
Extracorporeal photopheresis (ECP), is commonly used for the treatment of cutaneous T-cell
lymphoma (CTCL) and chronic graft-versus-host disease. ECP (cGVHD) is an immune modulating
treatment. White blood cells from the patient are standardized activated by a photosensitizer
psoralen (8-MOP) and irradiated with visible ultraviolet light (UV-A). The purpose is to
induce programmed cell death (apoptosis). Disadvantage of current treatment is that 8-MOP
targets both diseased and normal cells with no selectivity.
The purpose of this study is to improve the current ECP technology using aminolevulinic acid
(ALA) and UV light. ECP will be carried out in conventional manner except that 8-MOP will be
replaced with ALA. Systemic ALA / UV light is already approved and used in the detection and
treatment of disease in humans. The primary objective is to assess its safety and
tolerability after single and multiple treatment in patients with CTCL or cGvHD.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
St. Olavs Hospital
Collaborators:
Norwegian University of Science and Technology Oslo University Hospital