DRKS00003693
招募中
4 期
ADO CTCL-3 (Tarado): Multicentric therapy protocol for bexarotene (Targretin ®) monotherapy in pretreated CTCL stage =Ib with clear assignment to a EORTC-Diagnosis - Tarado
niversitätsklinikum Schleswig-Holstein Campus Kiel0 个研究点目标入组 200 人2012年12月5日
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- TCELLLYMPHOMA
- 发起方
- niversitätsklinikum Schleswig-Holstein Campus Kiel
- 入组人数
- 200
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Histopathologically documented CTCL stage \= Ib and grading by EORTC (Appendix K)
- •Staging, EORTC classification
- •2\. Pretreatment with PUVA if a continuation of the PUVA is no longer possible or with inadequate response
- •3\. Karnofsky performance status\> 60%
- •4\. Age \= 18 years
- •5\. Adequate organ function (blood count, liver, kidney, cardiac function, electrolytes, lipids)
- •6\. Neg. Pregnancy test, efficient contraception in male and female patients (bexarotene could lead to decreased efficacy of hormonal contraceptives)
- •7\. No other active malignancy
- •8\. No topical chemotherapy, photopheresis or interferon treatment to 28 days prior to study entry
- •9\. No topical treatment (steroids, tar\-bath), superficial radiotherapy, treatment with other retinoids or beta\-carotene two weeks ago baseline \*
排除标准
- •1\. Mucosal or ocular melanoma melanoma
- •2\. Intransitmetastasen
- •3\. Other adjuvant therapy (systemic therapy with an immunomodulator of a previous operation is allowed, provided that the last dose at least 30 days earlier; prior radiotherapy before lymphadenectomy is allowed)
- •4\. Autoimmune disorders (vitiligo außgenommen)
- •5\. Immunodeficiency
- •6\. Other malignancies (excluding carcinoma in situ of the cervix or remission over 5 years)
- •7\. Uncontrolled bleeding
结局指标
主要结局
未指定
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