Anti-Leukemia Immune Responses After Irradiation of Extramedullary Tumors
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes in anti-leukemia immune responses
研究概览
简要总结
This clinical trial assesses how the immune system responds to leukemia tumors after low dose radiation delivered as part of standard of care. The information learned in this study may help them know if adding immunotherapy (a type of treatment that uses the immune system to fight cancer) can be helpful in future leukemia patients receiving radiation.
详细描述
PRIMARY OBJECTIVES:
I. To identify changes in anti-leukemia immune responses after local radiotherapy to extramedullary sites.
II. Develop an annotated biospecimen panel of extramedullary leukemia biopsies prior to and after radiotherapy to examine local immune responses using transcriptional profiling, immunofluorescence and single cell analyses.
III. Define changes in the T cell receptor (TCR) clonotypes, functionality and inflammatory cytokine levels in peripheral blood leukocytes and serum.
IV. Correlate changes in anti-tumor immune responses with clinic-pathological variables and patient outcomes.
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
- •Patients diagnosed with new or recurrent myeloid leukemia
- •Aged >= 18 years old
- •Eastern Cooperative Oncology Group (ECOG) performance status < 4
- •Patient have measurable and amenable to biopsy under local anesthesia without the need for imaging directed procedure
- •Ability to understand and provide signed informed consent
- •Females must be surgically or biologically sterile or postmenopausal (amenorrhoeic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment. Women of childbearing potential must agree to use an adequate method of contraception during the study and until the last radiation treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study and until the last radiation treatment
排除标准
- •Patients who are unwilling to participate
- •Patients unwilling to undergo the biopsy before or after radiotherapy
研究组 & 干预措施
Treatment (biopsy, biospecimen collection)
Patients undergo biopsy prior to radiation therapy and 7-14 days after radiation therapy. Patients also undergo blood sample collection prior to therapy (within 7 days of starting radiation therapy), 1 and 7 days post completion of radiation therapy. Patients' photographs of the biopsy site are taken before and at 4-6 weeks post completion of radiation, and their medical records are reviewed for up to 2 years.
干预措施: Biopsy (Procedure)
Treatment (biopsy, biospecimen collection)
Patients undergo biopsy prior to radiation therapy and 7-14 days after radiation therapy. Patients also undergo blood sample collection prior to therapy (within 7 days of starting radiation therapy), 1 and 7 days post completion of radiation therapy. Patients' photographs of the biopsy site are taken before and at 4-6 weeks post completion of radiation, and their medical records are reviewed for up to 2 years.
干预措施: Biospecimen Collection (Procedure)
Treatment (biopsy, biospecimen collection)
Patients undergo biopsy prior to radiation therapy and 7-14 days after radiation therapy. Patients also undergo blood sample collection prior to therapy (within 7 days of starting radiation therapy), 1 and 7 days post completion of radiation therapy. Patients' photographs of the biopsy site are taken before and at 4-6 weeks post completion of radiation, and their medical records are reviewed for up to 2 years.
干预措施: Electronic Health Record Review (Other)
Treatment (biopsy, biospecimen collection)
Patients undergo biopsy prior to radiation therapy and 7-14 days after radiation therapy. Patients also undergo blood sample collection prior to therapy (within 7 days of starting radiation therapy), 1 and 7 days post completion of radiation therapy. Patients' photographs of the biopsy site are taken before and at 4-6 weeks post completion of radiation, and their medical records are reviewed for up to 2 years.
干预措施: Photography (Other)
结局指标
主要结局
Changes in anti-leukemia immune responses
时间窗: Through study completion, an average of 1 year
次要结局
未报告次要终点