Venetoclax (Venclexta Tablet) Post-Marketing Surveillance for AML Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 10
- 主要终点
- Percentage of Participants Who Reported Serious Adverse Event/Drug Reaction
研究概览
简要总结
Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective oral venetoclax is in participants with AML . Adverse events and change in disease activity will be monitored under routine clinical practice.
Venetoclax is an approved drug for treatment of Acute Myeloid Leukemia (AML). Around 600 participants of age 19 years and above will be enrolled in the study in multiple medical institutions across South Korea.
Participants will receive oral venetoclax tablets as prescribed by their physician in the routine clinical practice. Participants will be observed for 7 cycles ( each cycle is 28 days).
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-Acute Myeloid Leukemia (AML) participants who have been prescribed oral Venetoclax tablets for the first time according to the approved label.
排除标准
- •Participants with contraindications to Venetoclax as listed on the approved local label.
- •Participants receiving Venetoclax in clinical trials.
结局指标
主要结局
Percentage of Participants Who Reported Serious Adverse Event/Drug Reaction
时间窗: 32 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
次要结局
- Percentage of Participants who Achieved Complete Remission With Incomplete Hematologic Recovery (CRi)(28 weeks)
- The Percentage of Participants who Achieved Composite Complete Remission (CR+CRi)(28 weeks)
- Median Overall Survival [OS] (month)(28 weeks)
- Median Progression Free Survival [PFS] (month)(28 weeks)
- Percentage of Participants who Achieved Complete Remission (CR)(28 weeks)
- Median Time to Achieve Complete Remission [CR] (month)(28 weeks)
- Median Time to Achieve CRi(28 weeks)
- Overall Response Rate (ORR) Based on Effectiveness Outcome(28 weeks)