A Prospective, Multicenter, Single-Arm Cohort Study of Photopheresis in the Treatment of Erythrodermic MF and SS
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Success rate of treatment (photopheresis)
研究概览
简要总结
PROMPT: a study of photopheresis for the treatment of erythrodermic mycosis fungoides and Sézary syndrome
For this study, the investigators invite patients suffering from erythrodermic mycosis fungoides (MF) and Sézary syndrome (SS) whose skin symptoms have not responded to other types of treatment prescribed by their doctors (symptoms came back or got worse) as well as patients that never received any treatment.
Patients will be treated with photopheresis every two weeks for the first three months, thereafter once monthly. One treatment cycle consists of 2 day treatment in a row. After 6 months of treatment, treatment can be given every 5 to 8 weeks.
During the photopheresis procedure, the patient's blood is collected into a specialized machine (THERAKOS CELLEX) that separates the white blood cells from the other blood components. The other blood components are returned to the patient and white blood cells are then treated with the drug methoxsalen, which makes them sensitive to ultraviolet light. The treated white blood cells are exposed to ultraviolet A (UVA) irradiation inside the machine, and then returned to the patient.
As photopheresis has been used worldwide for more than 30 years, each hospital has developed their own guidelines (e.g. which patients, frequency, etc). Recently, experts in the field have developed a guidance which will now be tested in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Methoxsalen with the THERAKOS CELLEX Photopheresis System
Treatment will be performed according to a predefined protocol based on the consensus guidelines in patients with MF/SS. Treatment should be administered for one year unless confirmed disease progression or unless other criteria for treatment discontinuation are met as specified in the protocol.
干预措施: Methoxsalen (Drug)
Methoxsalen with the THERAKOS CELLEX Photopheresis System
Treatment will be performed according to a predefined protocol based on the consensus guidelines in patients with MF/SS. Treatment should be administered for one year unless confirmed disease progression or unless other criteria for treatment discontinuation are met as specified in the protocol.
干预措施: THERAKOS CELLEX Photopheresis System (Device)
结局指标
主要结局
Success rate of treatment (photopheresis)
时间窗: From treatment start up to 9 months for each patient
The primary endpoint is defined as successful use of photopheresis performed according to the study protocol based on the consensus guidelines. At 9 months time point after the initiation of photopheresis, evaluation of each patient will be performed. A patient will be declared a success with respect to the primary endpoint if she/he fulfills: 1. Patient has received the full protocol treatment 2. No progressive disease within the first 3 months after of the initiation of photopheresis. 3. No need for add-on (combination) treatment within the first 3 months after the initiation of photopheresis according to investigators decision. 4. Not experiencing any medical event (other than progressive disease) necessitating termination of photopheresis or interruption for more than 3 continuous months within the 6 months period
次要结局
- Progression Free Survival, according to EORTC-International Society of Cutaneous Lymphoma (ISCL)-United States Cutaneous Lymphoma Consortium (USCLC) criteria(From the first patient treatment start till 9 months as of LPI)
- Best overall response rates, according to EORTC-ISCL-USCLC criteria(From the first patient treatment start till 9 months as of LPI)
- Quality of life measurements(From the first patient treatment start till 9 months as of LPI)
- Number of treatment cycles required to obtain remission(From the first patient treatment start till 9 months as of LPI)
- Frequency and type of of add-on therapies(From the first patient treatment start till 9 months as of LPI)
- Time to response (CR/PR)(From the first patient treatment start till 9 months as of LPI)
- Duration of response(From the first patient treatment start till 9 months as of LPI)
- Occurrence of adverse events(From the first patient treatment start till 9 months as of LPI)
- Overall survival (OS)(From the first patient treatment start till 3 years as of LPI)
- Time to initiation of add-on therapies(From the first patient treatment start till 9 months as of LPI)