A Study of Molecular Subtyping-based Therapeutic Strategies for Cutaneous T-cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- time to next treatment (TTNT)
研究概览
简要总结
Cutaneous T-cell lymphoma (CTCL) is a group of diseases resulting from clonal hyperplasia of memory T cells in the skin. The increasing incidence and high treatment costs have posed significant challenges to public health and the economy. Current treatment guidelines only provide partial control, leading to varying remission times and recurrence rates. This study aims to use molecular subtyping and immunohistochemistry to guide treatment selection for CTCL patients, aiming to prolong clinical benefit, improve treatment safety, and reduce economic burden.
详细描述
The study focuses on the impact of treatment strategy selection based on molecular typing for patients with cutaneous T-cell lymphoma. The study aims to evaluate the effect on clinical benefit time and long-term prognosis, assess the safety of the treatment strategy, and explore the interaction between baseline factors and treatment regimens. This research could potentially provide valuable evidence for precision treatment in the context of cutaneous T-cell lymphoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent;
- •Patients with CTCL who do not respond well to targeted skin therapy (topical corticosteroids, nitrogen mustard, or phototherapy) in the early stage (stage I-IIA) and advanced stage (stage IIB-IV);
- •Age 18-75 years;
- •Expected survival time greater than 3 months (follow-up for the historical control group was greater than 3 months);
排除标准
- •Received other anti-tumor therapy other than skin-targeted therapy (phototherapy, topical hormones or nitrogen mustard) within the past 1 month prior to enrollment;
- •Patients with 2 or more types of primary cutaneous T-cell lymphoma at the same time;
- •Combined with other malignant tumors, still receiving anti-tumor therapy;
- •Has any other active disease that may increase the risk of protocol therapy or impair the patient's ability to receive protocol therapy, including but not limited to:
- •Comorbid epilepsy;
- •Comorbid autoimmune diseases;
- •Combined with hepatic decompensation;
- •Patients with renal insufficiency and creatinine clearance < 50ml/min;
- •Have an uncontrollable medical condition, including but not limited to:
- •Ongoing or active infection;
- •Clinically significant healing or non-healing wounds;
- •Symptomatic congestive heart failure, unstable angina, clinically significant arrhythmias;
- •Significant lung disease (e.g., shortness of breath at rest or light activity, or need for supplemental oxygen for any reason);
- •Diseases/conditions that affect study compliance, such as infectious diseases or psychiatric illnesses/social situations, that are uncontrollable;
- •Pregnant (or intending to become pregnant within 2 years) or lactating females;
- •Concomitant participation in interventional clinical trials of other clinical trial drugs, except for questionnaire surveys or observational studies;
- •Any situation in which the programme is not in compliance;
- •Other conditions that in the opinion of the investigator are not suitable for participation in this study.
结局指标
主要结局
time to next treatment (TTNT)
时间窗: From enrollment to the end of treatment at 2 years
The time to treatment failure (TTNT) is defined as the duration from the start of treatment to when the treatment is switched to the next systemic therapy or until the patient passes away. Introducing new skin-directed therapy (SDT) alongside topical therapy doesn't indicate treatment failure unless the systemic treatment is changed. If the skin lesion worsens and needs local radiotherapy, it's considered that the systemic therapy has failed. The date of discontinuation of systemic therapy is used when treatment is stopped due to disease progression without further treatment.
次要结局
- progression-free survival (PFS)(From enrollment to the end of treatment at 2 years)
- overall survival (OS)(From enrollment to the end of treatment at 2 years)
- objective response rate (ORR)(From enrollment to the end of treatment at 2 years)
- time to response (TTR)(From enrollment to the end of treatment at 2 years)
研究者
Yang WANG
The Chief of Department of Dermatology and Venereology
Peking University First Hospital