Modification of Extracorporeal Photopheresis in Cutaneous T-cell Lymphoma or Chronic Graft-versus-host Disease
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|ClinicalTrials.gov Identifier: NCT03109353|
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : May 15, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous T-Cell Lymphoma, Unspecified Chronic Graft Versus Host Disease in Skin||Drug: ECP with 5-aminolevulinic acid||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Modification of Extracorporeal Photopheresis Technology With 5-aminolevulinic Acid in Patients With Cutaneous T-cell Lymphoma or Chronic Graft-versus-host Disease - A Proof-of-concept Study|
|Actual Study Start Date :||September 20, 2017|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
Extracorporeal photopheresis (ECP) with 5-aminolevulinic acid replacing psoralen
Drug: ECP with 5-aminolevulinic acid
extracorporeal photopheresis (ALA-ECP) using 5-aminolevulinic acid instead of psoralen (8-MOP) in a maximum of 10 treatment cycles
Other Name: 5-ALA
- Treatment safety: Monitored through recordings of ECG, vital signs and safety laboratory measurements including haematology, clinical chemistry and urinalysis. [ Time Frame: up to 1 year ]Monitored through recordings of ECG, vital signs and safety laboratory measurements including haematology, clinical chemistry and urinalysis.
- Main efficacy for CTCL [ Time Frame: up to 1 year ]Response of skin disease and reduction in immunosuppression. Response will be evaluated with study baseline as reference as: complete response, partial response, minimal response, stable disease, progressive disease or maximal response based on set definitions.
- Main efficacy for cGvHD [ Time Frame: up to 1 year ]Response of skin disease and reduction in immunosuppression. Response will be evaluated with study baseline as reference as: complete response, partial response, minimal response, stable disease, progressive disease or maximal response based on set definitions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109353
|Contact: Eidi Christensen, md phd||0047 firstname.lastname@example.org|
|Contact: Qian Peng, md email@example.com|
|St Olavs Hospital||Recruiting|
|Contact: Eidi Christensen, md phd firstname.lastname@example.org|
|Study Director:||Vigleik Jessen, md||St Olavs Hospital, Trondheim Unversity Hospital|
|Study Director:||Torstein Baade Rø, md phd||Norwegian University of Science and Technology|