Characteristics, Treatment Patterns, and Clinical Outcomes in Non-intensive Chemotherapy Acute Myeloid Leukemia (AML) Patients - a US Real-World Study Using Electronic Medical Record Data
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Overall Survival
研究概览
简要总结
Among patients with a diagnosis of AML who received non-intensive chemotherapy:
- Describe patient demographic and clinical characteristics
- Describe treatment patterns
- Describe effectiveness outcomes
- Evaluate tumor response
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- •Confirmed diagnosis of AML on or after 01 January 2012 through Clinical Research Nurse (CRN) review of provider documentation of AML diagnosis in the medical record.
- •Receipt of non-intensive therapy at any point during first line therapy following initial AML diagnosis. For this study, non-intensive therapy will be defined as 1 of the following agents, alone or in combination with any other agent:
- •Age ≥18 years at initial diagnosis of AML.
排除标准
- •Patients meeting any of the following criteria will not be included in the study:
- •Record of 1 or more of the following confounding diagnoses at any point before or after AML diagnosis: Acute lymphoblastic leukemia; acute promyelocytic leukemia, aggressive systemic mastocytosis; hypereosinophilic syndrome and/or chronic eosinophilic leukemia; dermatofibrosarcoma protuberans; gastrointestinal stromal tumors.
研究组 & 干预措施
AML
Patients diagnosed with AML
干预措施: azacitidine (Drug)
AML
Patients diagnosed with AML
干预措施: venetoclax (Drug)
AML
Patients diagnosed with AML
干预措施: glasdegib (Drug)
结局指标
主要结局
Overall Survival
时间窗: January 1, 2012 to January 10, 2020
Overall survival was the duration from diagnosis of disease to death.
Relapse Free Survival
时间窗: January 1, 2012 to January 10, 2020
Time from the treatment initiation date to the date of a relapse event, or death from any cause, whichever comes first
Time to best response
时间窗: January 1, 2012 to January 10, 2020
Time from treatment initiation until best response recorded
Event Free Survival
时间窗: January 1, 2012 to January 10, 2020
Time from the treatment initiation date to the date of treatment failure (TF), relapse from CR or better, or death from any cause, whichever comes first
Best response
时间窗: January 1, 2012 to January 10, 2020
Best response recorded from treatment start until disease progression/recurrence
Duration of best response
时间窗: January 1, 2012 to January 10, 2020
Time from best response achieved until lose of response or the end of the record, whichever occurs first
次要结局
未报告次要终点