Prospective Multi-Center Observational Study to Assess Effectiveness of Venclexta (Venetoclax) in Population of Relapse or Refractory Chronic Lymphocytic Leukemia Patients in Routine Clinical Practice in Russian Federation (FORTE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 20
- 主要终点
- Objective Response Rate (ORR) 12 Months after Treatment Initiation
研究概览
简要总结
This study seeks to assess the effectiveness and safety of venetoclax in patients with relapsed and refractory chronic lymphocytic leukemia (CLL) in a real-world setting across clinical practice in the Russian Federation.
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
- •Has a confirmed diagnosis of relapsed or refractory CLL.
- •Patient for whom the physician has decided to initiate CLL treatment with venetoclax (mono and combo therapy), or up to 4 weeks after venetoclax treatment initiation
- •Patient voluntarily agrees to participate in this study and signs informed consent form
排除标准
- •Has contraindications to venetoclax as listed on the approved local label in Russian Federation.
- •Has Richter syndrome
- •Participated in a clinical trial with an investigative drug for CLL within 30 days prior to treatment initiation
研究组 & 干预措施
Venetoclax
Participants in this observational study will receive treatment with venetoclax for up to 24 months for treatment of relapsed or refractory CLL.
The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.
干预措施: Venetoclax (Drug)
结局指标
主要结局
Objective Response Rate (ORR) 12 Months after Treatment Initiation
时间窗: Up to approximately 12 months after treatment initiation
ORR is defined as the percentage of participants who reach either complete remission (CR), CR with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) to treatment.
次要结局
- Objective Response Rate (ORR) 24 Months after Treatment Initiation(Up to approximately 24 months after treatment initiation)
- Time To Next Treatment(Up to approximately 24 months)
- Overall Survival (OS) Rate(Up to approximately 24 months)
- Percentage of Patients with Undetectable Minimal Residual Disease (MRD)(Up to approximately 24 months)
- Progression-free Survival (PFS)(Up to approximately 24 months)
- Time to First Response to Treatment(Up to approximately 24 months)
- Time to Best Response to Treatment(Up to approximately 24 months)
- Duration of Response (DoR)(Up to approximately 24 months)
- Change from Baseline in RAND Short Form (SF)-36 Questionnaire(Up to approximately 24 months)