JPRN-jRCTs041180094已完成4 期
Efficacy and safety of Targretin alone or in combination with phototherapy in Japanese patients with cutaneous T-cell lymphoma (CTCL) - C-Little
Morita Akimichi0 个研究点目标入组 53 人开始时间: 2019年3月13日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
研究概览
简要总结
We conducted the comparative study on the efficacy and safety between the Targretin monotherapy and the Targretin+phototherapy combination therapy for CTCL. In the efficacy, no difference was observed in the therapeutic effect of the two therapies evaluated by mSWAT and PGA at 8 weeks, but the two therapies have been shown to have therapeutic effects. In the combination therapy, 4 subjects were diagnosed to be the CR, and it was suggested that the combination therapy may have a high effect.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •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. Skin-directed therapies, local chemotherapy, topical steroids, etc. within 2 weeks of study entry. Low- and mid-potency topical corticosteroids were allowed only for subjects using a stable dose regimen at least 2 weeks prior to study entry. High potency topical corticosteroids were not allowed permitted.
- •4. Prior therapy for the treatment of CTCL: therapy with UVA or UVB within 3 weeks of study entry
- •5. Prior therapy for the treatment of CTCL: radiotherapy within 4 weeks of study entry
- •6. Prior therapy for the treatment of CTCL: therapy with bexarotene within 4 weeks of study entry
- •7. Known allergic reaction or hypersensitivity to bexarotene or other component of Targretin capsules
- •8. History of severe allergic reaction or hypersensitivity to any other drugs or prior therapy for the treatment of CTCL
- •9. Unwillingness or inability to minimize exposure to sunlight and artificial UC light while receiving bexarotene
- •10. Principal investigator or subinvestigator judged inadequate
研究者
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