NCT04159779进行中（未招募）不适用
Clinical Outcomes of Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in Routine Clinical Settings in Greece
AbbVie21 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年1月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
- 试验地点
- 21
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This study is being done to evaluate the clinical outcomes of Chronic Lymphocytic Leukemia (CLL) participants treated with venetoclax as routine standard of care in Greece. The decision to treat with venetoclax is made by the participant's physician prior to being offered enrollment in this study.
The objectives of this study include determining overall response rate, assessing safety information, analyzing patient profiles and disease characteristics and participant quality of life.
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 Chronic Lymphocytic Leukemia (CLL) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
- •Eligible to receive venetoclax as per local label
- •Physician has decided to initiate CLL treatment with venetoclax and the decision to treat is made by the physician in accordance with the local label prior to any decision to approach the participant about the study
- •Participant has been fully informed verbally and in writing about the study and does not object to their data being processed or subjected to data quality control
排除标准
- •Prescribed or treated with venetoclax outside of marketing authorization
- •Currently participating in, or previously participated within 30 days prior to venetoclax start, in any other interventional clinical trial
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: At Month 12
Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines and includes partial response (PR), nodular partial response (nPR), complete response with incomplete bone marrow recovery (CRi), and complete response (CR).
次要结局
- Complete Response (CR)(Up to Month 36)
- Time to Progression (TTP)(Up to Month 36)
- Overall Response Rate (ORR)(Up to Month 36)
- Nodule Partial Response (nPR) Rate(Up to Month 36)
- Number of Lines of Prior Therapy in Participants with Relapse/Refractory Chronic Lymphocytic Leukemia(Up to Month 36)
- Treatment Duration(Up to Month 36)
- Change in Patient Reported Outcomes(From Baseline (Week 0) Up to Month 36)
- Percentage of Participants with Undetectable Minimal Residual Disease (uMRD)(Up to Month 36)
- Percentage of Participants with Dose Modifications(Up to Month 36)
- Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate(Up to Month 36)
- Partial Response (PR) Rate(Up to Month 36)
- Percentage of Participants With Disease Progression or Death(Up to Month 36)
- Progression Free Survival (PFS)(Up to Month 36)
- Overall Survival (OS)(Up to Month 36)
- Percentage of Participants with Adverse Drug Reactions (ADR)(Up to Month 36)
研究者
研究点 (21)
Loading locations...
相似试验
招募中
3 期
A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination with Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)Chronic Lymphocytic Leukemia2024-512147-23-00AbbVie Deutschland GmbH & Co. KG170
进行中（未招募）
不适用
A Study to Assess Change in Functioning and Health Related Quality of Life in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Treatments in Routine Clinical Practice in SpainChronic Lymphocytic LeukemiaNCT06125795AbbVie146
尚未招募
不适用
Outcomes of Unfit Patients With CLL Included in the GIMEMA LLC1114 Trial Who Discontinued Ibrutinib Due to Reasons Other Than Disease ProgressionChronic Lymphocytic LeukemiaNCT06084923Gruppo Italiano Malattie EMatologiche dell'Adulto73
招募中
2 期
Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)Chronic Lymphocytic Leukemia (CLL)NCT04895436AbbVie75
已完成
3 期
FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed PatientsChronic Lymphocytic LeukemiaNCT00090051Hoffmann-La Roche552