Prospective Analysis of Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Non-Relapse Mortality (NRM) in Frail, Pre-Frail, and Non-Frail patients
研究概览
简要总结
The purpose of this research study is to determine if frailty assessments can be used to predict how well patients aged 60 years and older will do after chemotherapy, CAR T-cell therapy, or allogeneic stem cell transplant.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Eligibility Criteria Arm A:
- Age 60 years or older.
- New diagnosis of Acute Leukemia or MDS, or suspected diagnosis.
- Able to consent to the study.
- Eligibility Criteria Arm B:
- Age 60 years or older with a hematologic malignancy.
- Plan to undergo an allogeneic blood or marrow transplantation or CAR T-cell therapy.
- Able to consent to the study.
排除标准
- 未提供
研究组 & 干预措施
Cancer Directed Therapy or Best Supportive Care
Cancer-directed therapy with intensive regimens, clinical trial, hypomethylating agent, hypomethylating agent combinations, targeted agents alone, or best supportive care
干预措施: Cancer-directed Therapy or Best Supportive Care (Other)
Cancer Directed Therapy or Best Supportive Care
Cancer-directed therapy with intensive regimens, clinical trial, hypomethylating agent, hypomethylating agent combinations, targeted agents alone, or best supportive care
干预措施: Frailty Assessment (Diagnostic Test)
Transplant
Bone marrow or peripheral blood graft (BMT) or CAR T-cell therapy
干预措施: Bone Marrow or Peripheral Blood Graft (BMT) (Procedure)
Transplant
Bone marrow or peripheral blood graft (BMT) or CAR T-cell therapy
干预措施: Frailty Assessment (Diagnostic Test)
结局指标
主要结局
Non-Relapse Mortality (NRM) in Frail, Pre-Frail, and Non-Frail patients
时间窗: 1-month
NRM will be defined as death without evidence of disease progression or relapse.
次要结局
- NRM by Intensity of Treatment(1-month and 6-month)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT03680677
- 其他研究编号
- UPCC 06718, 831340
日期
- 首次提交
- (8年前)
- 首次发布
- (8年前)
- 主要完成日期
- (12个月后)
- 研究完成日期
- (明年)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否