NCT06565975已完成不适用
RELION Study: Characteristics and Outcomes of the Patient Population With Acute Myeloid Leukemia in Remission, Treated With Oral Azacitidine Maintenance in France
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2023年5月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Participant real-world relapse-free survival (rw-RFS)
研究概览
简要总结
The purpose of this study is to collect and evaluate real-world data to describe the outcomes, patient characteristics, safety profile and treatment patterns of oral azacitidine prescribed as maintenance treatment after frontline treatment or second remission for acute myeloid leukemia in France.
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
- •Participants who initiated oral azacitidine maintenance therapy during early access program (EAP) in France (January 29, 2021 to July 13, 2022) or during the 6 months post-EAP (from July 14, 2022, to January 2014, 2023) inside the marketing authorization label "adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT)."
- •Participants with histologically confirmed diagnosis of de novo AML, or therapy-related AML, or secondary AML
- •Participants who received frontline treatment after diagnosis of AML and achieved complete remission (CR), CR with incomplete blood count recovery (Cri), or CR with partial hematology recovery (CRh) after one or subsequent lines of therapy in case of relapse
- •Participant is at least 18 years of age at the time of initial diagnosis of AML
- •Participants alive or deceased at the time of data collection
- •Physician has access to the complete medical record for the patient, including any transferred records from other facilities (if applicable); patient's medical record must at least include the following:
- •Date of diagnosis of AML
- •Frontline therapy(ies) received, and treatment start dates
- •Date(s) of first documented evidence of response
- •Oral azacitidine start and (if applicable) stop date
- •Documentation (yes/no) of relapse on oral azacitidine, where applicable
- •Participants who do not object to the data collection
排除标准
- •Participants who initiated maintenance with oral azacitidine after January 14, 2023
- •Participant who initiated maintenance with oral azacitidine before January 14, 2023, outside of the marketing authorization label
研究组 & 干预措施
Participants that received maintenance treatment of oral azacitidine
干预措施: Oral azacitidine (Drug)
结局指标
主要结局
Participant real-world relapse-free survival (rw-RFS)
时间窗: Up to date of documented relapse or death assessed up to 41 months
Participant overall survival (OS)
时间窗: Up to date of documented death assessed up to 41 months
Participant relapsed-free survival (RFS)
时间窗: From date of achieved complete remission up to 41 months
Participant overall survival (OS) from the time of complete remission achievement
时间窗: From date of achieved complete remission up to 41 months
Participant relapse rate
时间窗: 6 and 12 months
Time to treatment discontinuation (TTD)
时间窗: Up to 41 months
次要结局
- Participant baseline demographics(Baseline)
- Participant cytogenetic and mutational risk category(Baseline)
- Participant hemoglobin levels(Baseline)
- Participant acute myeloid (AML) classification as per World Health Organization(Baseline)
- Participant bone marrow blast percentage(Baseline)
- Participant blood test results(Baseline)
- Participant treatment history(Baseline)
- Participant response type at the initiation of maintenance therapy(Up to 41 months)
- Oral azacitidine treatment regimen(Up to 41 months)
- Criteria to define complete remission (CR), incomplete blood count recovery (Cri), and CR with partial hematology recovery (CRh) at time of initiation of oral azacitidine(Baseline)
- Type of acute myeloid (AML)(Baseline)
- Participant cytogenetic abnomalities(Baseline)
- Participant gene mutation status(Baseline)
- Participant Eastern Cooperative Oncology Group or Karnofsky score(Baseline)
- Participant diagnosis history of other hematological disorders(Baseline)
- Minimal residual disease status (MRD)(Baseline)
- Reason for stem cell transplant ineligibility post initial frontline treatment(Baseline)
- First versus subsequent remission at the time of initiation of treatment with oral azacitidine(Baseline)
- Concomitant support treatment received with oral azacitidine(Up to 41 months)
- Duration of oral azacitidine treatment(Up to 41 months)
- Reason for oral azacitidine treatment discontinuation(Up to 41 months)
- Treatments/procedures following oral azacitidine cessation(Up to 41 months)
- Participant adverse events (AEs)(Up to 41 months)
研究者
研究点 (1)
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