A Single Arm Pilot Study of Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The percentage of patients that completely respond to treatment
研究概览
简要总结
This is a single arm, single stage pilot study of radiation therapy plus durvalumab for tumor-stage cutaneous T-cell lymphoma (CTCL).
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
- •Voluntarily provide written IRB-approved consent
- •Age ≥ 18 years
- •Histologically proven CTCL
- •Stage IIB-IV CTCL with ≥2 cutaneous tumors assessable for response
- •At least one cutaneous tumor amenable to radiation therapy. Must have at least 1 tumor assessable for response that will not undergo radiation.
- •Adequate organ function
- •Prior treatment is allowed if at least 4 weeks have elapsed since last chemotherapy and/or radiation and the subject has recovered from all treatment related toxicity
排除标准
- •Prior allogeneic stem cell transplant.
- •Prior treatment with a PD-1/PD-L1 inhibitor
- •Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment.
- •Current or prior use of immunosuppressive medication within 14 days prior to first dose of durvalumab.
- •Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.
- •History of hypersensitivity to durvalumab or any excipient
- •Receipt of live attenuated vaccination within 30 days prior the first dose of durvalumab.
- •Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control
- •Male subjects who are not employing an effective method of birth control
- •Uncontrolled current medical illness, including, but not limited to ongoing or active infections, symptomatic congestive heart failure, unstable angina pectoris,unstable cardiac arrhythmia and/or psychiatric illness or other condition that in the opinion of the investigator would limit compliance with study requirements.
研究组 & 干预措施
Radiation Therapy + Durvalumab
Radiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions) Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days.
干预措施: Durvalumab (Drug)
Radiation Therapy + Durvalumab
Radiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions) Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days.
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
The percentage of patients that completely respond to treatment
时间窗: 1 year post treatment
Complete Response Rate (CRR) is defined as the percentage of patients that obtain Complete Response (CR) to treatment. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
The percentage of patients that respond to treatment
时间窗: 1 year post treatment
Overall Response Rate (ORR) is defined as the percentage of patients that obtain a Complete Response (CR) or Partial Response (PR) to treatment. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
次要结局
- Time to response(1 year post treatment)
- Progression free survival time(1 year post treatment)
- Duration of overall response(1 year post treatment)
- Time to next treatment(1 year post treatment)