Prospective Multi-Center Observational Study to Assess Effectiveness of Venclexta (Venetoclax) in Combination With Obinutuzumab in Population of Previously Untreated Chronic Lymphocytic Leukemia Patients in Routine Clinical Practice in Russian Federation (FIRST)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Percentage of Participants Achieving Overall Response Rate (ORR) Best Response
研究概览
简要总结
Chronic Lymphoid Leukemia (CLL) is the most common type of leukemia (cancer of blood cells) in adults affecting men more so than women. The main objective of this study is to assess the how effective venetoclax (Venclexta) in combination with Obinutuzumab is in treating Chronic Lymphocytic Leukemia (CLL). Effectiveness is assessed by achievement of best response.
Venetoclax is an approved drug developed for the treatment of CLL. Approximately 50 adult participants with previously untreated CLL will be enrolled in approximately 10 to 15 sites in Russian Federation.
Participants will receive oral venetoclax tablets in combination with intravenous (IV) Obinutuzumab as prescribed by the physician prior to enrolling in this study in accordance to the local practice and label.
There may be a higher burden for participants in this study compared to 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of previously untreated Chronic Lymphocytic Leukemia (CLL).
- •Participant for whom the physician has decided to initiate CLL treatment with Venetoclax combo therapy with Obinutuzumab, according to approved local label up to 4 weeks (28 days) after Obinutuzumab treatment initiation.
排除标准
- •Contraindications to Venclexta (Venetoclax) as listed on the approved local label in Russian Federation.
- •Creatinine Clearance < 30 milliLitres/minute.
- •Richter syndrome or Transformation of CLL to aggressive non-Hodgkin lymphoma.
- •Participating in a clinical trial with an investigative drug for CLL.
结局指标
主要结局
Percentage of Participants Achieving Overall Response Rate (ORR) Best Response
时间窗: Up to approximately 36 Months
ORR is defined as complete remission (CR) + complete remission with incomplete bone marrow recovery (CRi) + partial remission (PR) + nodular partial remission (nPR).
次要结局
- Time to First Response(Up to approximately 36 Months)
- Time to Next Treatment(Up to approximately 36 Months)
- Percentage of Participants Achieving Objective Response Rate (ORR)(Up to 12 Months)
- Time to Best Response(Up to approximately 36 Months)
- Minimal Residual Disease (MRD)(Up to 36 Months)
- Duration of Response (DoR)(Up to approximately 36 Months)
- Progression-Free Survival (PFS)(Up to 36 Months)
- Number of Participants With Adverse Events (AEs)(Up to approximately 36 Months)
- Overall Survival (OS)(Up to 36 Months)