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Phase I Study of Topical Romidepsin in Early Stage Cutaneous T-cell Lymphoma

Phase I Study of Topical Romidepsin in Early Stage Cutaneous T-cell Lymphoma
局部用罗米地辛治疗早期皮肤 T 细胞淋巴瘤的 I 期研究
批准号：
7733333
负责人：
Heidi Kong
金额：
$0.94万
依托单位：
DIVISION OF BASIC SCIENCES - NCI
依托单位国家：
美国
项目类别：
财政年份：
--
资助国家：
美国
项目状态：
未结题
起止时间：
至
来源：
https://reporter.nih.gov/project-details/7733333
关键词：
Adverse effectsBiological MarkersBiopsyBloodCD4 Positive T LymphocytesCarmustineChronicClinical TrialsClinical trial protocol documentCutaneousCutaneous LymphomaDepsipeptidesDiseaseDoseDrug KineticsElectron Beam TherapyErythemaEvaluationFicusinHistologyHistone Deacetylase InhibitorIndividualIonizing radiationMechlorethamineMycosis FungoidesNon-Hodgkin&aposs LymphomaPatientsPharmaceutical PreparationsPhase I Clinical TrialsPhotographyPhototherapyPhysical ExaminationPruritusPsoralensQuality of lifeRadiationRadiation therapyRecruitment ActivityRecurrenceRefractoryResearchRiskSafetySkinSkin CancerStagingT-Cell LymphomaTimeUltraviolet RaysVorinostatcostresearch studyskin disorder

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中文摘要
翻译
我们一直在积极招募外用罗米地辛(去脂肽)治疗早期真菌样肉芽肿(一种罕见的皮肤淋巴瘤)的安全性和有效性的临床试验方案。在2008财年，我们完成了两个剂量水平。每个剂量水平评估包括通过体检、药物耐受性、瘙痒、生活质量、使用色度计的红斑、使用标准化工作室设置的摄影、用于副作用评估和药代动力学的研究血液以及用于常规组织学和特殊研究的皮肤活检来重复评估皮肤病。
英文摘要
We have been actively recruiting for this clinical trial protocol of the safety and efficacy of topical romidepsin (depsipeptide) in early stage mycosis fungoides (a rare type of skin lymphoma). In fiscal year 2008, we completed two dose levels. Each dose level evaluation includes repeated assessments of skin disease through physical examination, medication tolerability, pruritus, quality of life, erythema with the use of colorimeter, photography using a standardized studio set-up, research blood for side effect evaluation and pharmacokinetics, and skin biopsies for routine histology and special research studies.
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