UMIN000029537.
Study name | Efficacy and safety of Targretin capsule 75‐mg alone or in combination with phototherapy in Japanese patients with cutaneous T‐cell lymphomas |
Methods | This is a randomised controlled trial comparing bexarotene alone vs. bexarotene plus phototherapy for cutaneous T‐cell lymphoma (CTCL) patients. |
Participants |
Inclusion criteria
Exclusion criteria
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Interventions | Arm I Patients receive are administrated a 300 mg/m2 dose of bexarotene orally once daily for 8 weeks. Arm II Patients are administrated a 300 mg/m2 dose of bexarotene orally once daily for 8 weeks. Patients are treated with psoralen baths preceding treatment with UVA radiation 5 times weekly. The initial dose of UVA was 0.5 J/cm2, dose increment of 0.5 J/cm2 each radiation. The maximum dose was 4.0 J/cm2. The initial dose of narrowband UVB administered is 50% to 70% of the MPD or 0.5‐0.7 J/cm2. The dose of NB‐UVB for the subsequent NB‐UVB sessions is elevated 20% increments with each successive treatment session. The maximum dose is 2.0 J/cm2. |
Outcomes |
Primary outcomes of the study
The primary efficacy end points evaluated though the 8 weeks of treatment were follows: Modified Severity‐weighted Assessment Tool (mSWAT), Physician's Global Assessment (PGA). Secondary outcomes of the study Efficacy: time to cutaneous tumour response, time to cutaneous tumour progression, amount of irradiation and UV dose, amount of bexarotene, capsules, and compliance rate, LDH, sIL‐2R, TARC, T‐cell receptor repertoire analysis Safety: adverse events, haematology, blood chemistry |
Starting date | 2017 |
Contact information |
Sponsors and collaborators
Minophagen Pharmaceutical Co., Ltd. Investigators Principal Investigator: Akimichi Morita |
Notes | ‐ |