Outcomes After Chimeric Antigen Receptor Therapy (CAR-T) and Radiation Therapy (RT) for Hematologic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical outcomes of patients with hematologic malignancies receiving standard-of-care chimeric antigen receptor therapy (CAR-T) and radiation therapy (RT)
研究概览
简要总结
This study collects information on outcomes after chimeric antigen receptor therapy and radiation therapy for hematologic malignancies. Collecting information from patients before, during, and after receiving chimeric antigen receptor therapy or radiation therapy may help doctors to optimize patient selection, dose, timing, and sequencing of these treatments.
详细描述
PRIMARY OBJECTIVE:
I. Record clinical outcomes of patients with hematologic malignancies receiving standard-of-care chimeric antigen receptor therapy (CAR-T) nd/or standard-of- care bispecific therapy, and radiation therapy (RT).
SECONDARY OBJECTIVES:
I. To record patient-specific factors and treatment-related factors in patients with hematologic malignancies receiving standard-of-care CAR-T, and/or standard-of-care bispecific therapy, and RT to ultimately improve patient selection and overall treatment strategy to optimize clinical outcomes. II. To record and explore the relationship between radiation dose, target, technique, and timing with respect to CAR-T, and/or standard-of-care bispecific therapy and clinical outcomes in patients with hematologic malignancies treated with standard-of-care CAR-T, and/ or standard-of-care bispecific therapy, and RT.
III. To record and study the relationship between patient-specific factors and treatment-related factors and treatment toxicity in patients with hematologic malignancies undergoing standard-of-care CAR-T, and/or standard-of-care bispecific therapy, and RT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 years or older
- •Treatment with or intention to treat with radiation therapy, standard-of-care CAR-T cell therapy and/or standard-of-care bispecific therapy, within a 90 day window for a hematologic malignancy
排除标准
- 未提供
研究组 & 干预措施
Observational (data collection)
Patients medical records are reviewed for details about CAR-T and RT treatment and acute and late toxicities, disease outcomes such as any events related to local or distant disease progression, survival, and cause of death if available. Patients' imaging scan data is collected at baseline, within 2 months of the first treatment of RT or CAR-T, and at 3, 6, 12 months, and then annually for 5 years after RT completion.
干预措施: Data Capture (Other)
Observational (data collection)
Patients medical records are reviewed for details about CAR-T and RT treatment and acute and late toxicities, disease outcomes such as any events related to local or distant disease progression, survival, and cause of death if available. Patients' imaging scan data is collected at baseline, within 2 months of the first treatment of RT or CAR-T, and at 3, 6, 12 months, and then annually for 5 years after RT completion.
干预措施: Electronic Medical Record (Other)
结局指标
主要结局
Clinical outcomes of patients with hematologic malignancies receiving standard-of-care chimeric antigen receptor therapy (CAR-T) and radiation therapy (RT)
时间窗: Up to 5 years
Outcome measures will include the following: date and type of disease progression, time to lymphoma progression, progression confirmed on biopsy (yes/no), disease control within the radiation field, survival and date of death, cause of death, overall response rate/best response achieved, duration of response, Toxicities including adverse events (CTCAE v 5.0), Neurotoxicity (ICANS) and cytokine release syndrome grade
次要结局
- Relationship between radiation dose, target, technique, and timing with respect to CAR-T and clinical outcomes(Up to 5 years)
- Patient-specific factors and treatment-related factors(Up to 5 years)
- Relationship between patient-specific factors and treatment-related factors and treatment toxicity(Up to 5 years)