Long-term Use of Romidepsin in Patients With CTCL
关键词
抽象
描述
This project is a retrospective and prospective chart review of patients who present at Northwestern Medical Faculty Foundation clinic with the diagnosis of CTCL. It includes Mycosis Fungoid, Sézary Syndrome and other subtypes of CTCL, like Cytotoxic Cutaneous T-cell lymphomas. Those patients that received or will be prescribed per standard of care with romidepsin for at least 1 month (or at least more than 1 cycle of treatment) will be reviewed. We estimate that 50 patients could fit the criteria above, since the drug started to be prescribed in the Dermatology Clinic. Clinical information regarding diagnosis, stage, prior treatment received, and therapeutic response will be recorded. Blood parameters such as cell blood count, calcium, magnesium, potassium, and albumin at baseline and after treatment with romidepsin will be reviewed, and recorded if abnormalities are detected. Electrocardiogram changes will also be checked and recorded. All the information will be gathered in an excel spreadsheet in order to perform a descriptive analysis. We aim to assess the use of romidepsin as maintenance therapy and assess which schedule of treatment was most frequently used and associated with a better response with fewer side effects.
日期
最后验证: | 02/29/2016 |
首次提交: | 10/01/2014 |
提交的预估入学人数: | 11/16/2014 |
首次发布: | 11/19/2014 |
上次提交的更新: | 03/09/2016 |
最近更新发布: | 03/10/2016 |
实际学习开始日期: | 12/31/2014 |
预计主要完成日期: | 06/30/2015 |
预计完成日期: | 07/31/2015 |
状况或疾病
干预/治疗
Drug: Romidepsin therapy
相
手臂组
臂 | 干预/治疗 |
---|---|
Romidepsin therapy Patients who received romidepsin per standard of care practice or included in other clinical trials (when receiving romidepsin therapy). | Drug: Romidepsin therapy Received romidepsin per standard of care or through a clinical trial for more than one cycle |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
取样方式 | Non-Probability Sample |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Patients with the diagnosis of Cutaneous T-cell Lymphoma who present to the Northwestern Medical Faculty Foundation Dermatology clinic between January 1, 2009 and December 31, 2014 - Stages with more than 20% of bosy surface area affected or higher for MF and SS, and other CTCL variants - Patients treated with romidepsin - Between 18 and 89 years Exclusion Criteria: - Patients under 18 and over 89 years - Patients with the diagnosis of CTCL that did not received romidepsin as a treatment |
结果
主要结果指标
1. Free disease time with maintenance therapy with romidepsin [4 weeks]