Unique ID issued by UMIN | UMIN000024532 |
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Receipt number | R000028222 |
Scientific Title | Efficacy and safety of bexarotene combined with phototherapy in Japanese patients with Cutaneous T-cell Lymphomas |
Date of disclosure of the study information | 2016/10/24 |
Last modified on | 2018/05/08 11:45:48 |
Efficacy and safety of bexarotene combined with phototherapy in Japanese patients with Cutaneous T-cell Lymphomas
Efficacy and safety of bexarotene combined with phototherapy in Japanese patients with Cutaneous T-cell Lymphomas
Efficacy and safety of bexarotene combined with phototherapy in Japanese patients with Cutaneous T-cell Lymphomas
Efficacy and safety of bexarotene combined with phototherapy in Japanese patients with Cutaneous T-cell Lymphomas
Japan |
Cutaneous T-Cell Lymphomas
Dermatology |
Malignancy
NO
To assess the efficacy and safety of bexarotene combined with phototherapy for cutaneous T-cell lymphoma patients
Safety,Efficacy
Confirmatory
Not applicable
Modified Severity-weighted Assessment Tool (mSWAT)
Physician's Global Assessment (PGA)
Safety: adverse events, hematology, blood chemistry, computed tomography of the abdomen and pelvis, ophthalmologic slit lamp examinations
Efficacy: LDH, sIL-2R, biopsy, response rate, duration of response, amount of irradiation and UV dose
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Device,equipment |
Patients are p.o. administrated a 300 mg/m2 dose of bexarotene once daily for 24 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 50-70% of the MPD or 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.
20 | years-old | <= |
Not applicable |
Male and Female
Subjects must have met all of the following inclusion criteria:
1. A clinical diagnosis of cutaneous T-cell lymphomas confirmed by biopsy to be histologically consistent with CTCL diagnosis by dermatopathologist
2. Age >= 20, written approval of patient
1. Contraindications (severe liver failure, known hypersensitivity to bexarotene, systemic therapy with vitamin A or oral retinoid therapy at the entry in this study, hypervitaminosis A)
2. Patients with pregnancy, breast-feeding or intent to become pregnant
3. Principal investigator or subinvestigator judged inadequate
25
1st name | |
Middle name | |
Last name | Akimichi Morita |
Nagoya City University Graduate School of Medical Sciences
Department of Geriatric and Environmental Dermatology
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
052-853-8261
amorita@med.nagoya-cu.ac.jp
1st name | |
Middle name | |
Last name | Akimichi Morita |
Nagoya City University Graduate School of Medical Sciences
Department of Geriatric and Environmental Dermatology
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
052-853-8261
amorita@med.nagoya-cu.ac.jp
Nagoya City University Graduate School of Medical Sciences
Department of Geriatric and Environmental Dermatology
Minophagen Pharmaceutical Co., Ltd.
Profit organization
Osaka City University Graduate School of Medicine
NO
名古屋市立大学,大阪市立大学
2016 | Year | 10 | Month | 24 | Day |
Unpublished
Completed
2016 | Year | 10 | Month | 05 | Day |
2016 | Year | 10 | Month | 24 | Day |
2016 | Year | 10 | Month | 24 | Day |
2018 | Year | 05 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028222
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