Application of Photodynamic Therapy with 5-Aminolevulinic Acid to Extracorporeal Photopheresis in the Treatment of Cutaneous T-Cell Lymphoma: A First-in-Human Phase I/II Study

被引:1
作者
Christensen, Eidi [1 ,2 ,3 ]
Foss, Olav Andreas [4 ]
Holien, Toril [5 ,6 ]
Juzenas, Petras [3 ]
Peng, Qian [3 ,7 ]
机构
[1] Trondheim Reg & Univ Hosp, St Olavs Hosp, Dept Dermatol, N-7030 Trondheim, Norway
[2] Norwegian Univ Sci & Technol NTNU, Dept Clin & Mol Med, N-7030 Trondheim, Norway
[3] Oslo Univ Hosp, Dept Pathol, Norwegian Radium Hosp, N-0310 Oslo, Norway
[4] Trondheim Reg & Univ Hosp, St Olavs Hosp, Dept Orthopaed Surg, Clin Orthopaed Rheumatol & Dermatol, N-7030 Trondheim, Norway
[5] Norwegian Univ Sci & Technol NTNU, Dept Biomed Lab Sci, N-7491 Trondheim, Norway
[6] Trondheim Reg & Univ Hosp, St Olavs Hosp, Dept Immunol & Transfus Med, N-7030 Trondheim, Norway
[7] Fudan Univ, Sch Informat Sci & Technol, Dept Opt Sci & Engn, Shanghai 200433, Peoples R China
关键词
5-aminolevulinic acid; ALA-based photodynamic therapy; phototherapy; extracorporeal photopheresis; cutaneous T-cell lymphoma; CLINICAL-RESEARCH; SKIN-DISEASE;
D O I
10.3390/pharmaceutics16060815
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Extracorporeal photopheresis (ECP) is a therapeutic modality used for T-cell-mediated disorders. This approach involves exposing isolated white blood cells to photoactivatable 8-methoxypsoralen (8-MOP) and UVA light, aiming to induce apoptosis in T-cells and thereby modulate immune responses. However, conventional 8-MOP-ECP lacks cell selectivity, killing both healthy and diseased cells, and has shown limited treatment efficacy. An alternative approach under investigation involves the use of 5-aminolevulinic acid (ALA) in conjunction with light, referred to as ALA-based photodynamic therapy. Our previous ex vivo studies suggest that ALA-ECP exhibits greater selectivity and efficiency in killing T-cells derived from patients with T-cell-mediated disorders compared to those treated with 8-MOP-ECP. We have conducted a clinical phase I-(II) study evaluating ALA-ECP safety and tolerability in cutaneous T-cell lymphoma (CTCL). Here, 20 ALA-ECP treatments were administered to one CTCL patient, revealing no significant changes in vital signs. Two adverse events were reported; both evaluated by the Internal Safety Review Committee as non-serious. In addition, five conceivable events with mainly mild symptoms took place. During the study period, a 53% reduction in skin involvement and a 50% reduction in pruritus was observed. In conclusion, the results indicate that ALA-ECP treatment is safe and well tolerated.
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页数:12
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