跳至主要内容
临床试验/NCT04746950
NCT04746950已完成不适用

ALICIA (Observational Prospective Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Russia)

AstraZeneca14 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
90
试验地点
14
主要终点
• progression-free survival (rwPFS) in patients with CLL who are treated with acalabrutinib in clinical practice in Russia

研究概览

简要总结

This is a multicenter non-interventional observational study conducted with a single hand arm to collect real-world data. In this study, commercially available acalabrutinib will be used as prescribed treatment for CLL as per the treating physician's best clinical judgement. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.

A multi-center collaborative effort in 15 centers selected from regions within Russia will help capture more patients into the database, rather than limiting the data to a single institution. This will be critical for:

  • increasing database sample size
  • reducing bias (single institution bias)
  • increasing result's generalizability to the whole Russian population Being an observational study, only data available from routine clinical practice and standard of care (SoC), in line with national and international laws and regulations, will be recorded.

Patients will be treated according to prescribing information, with visit frequency and assessments performed according to routine medical practice and SoC. Only data corresponding to these visits and assessments will be collected as part of the study.

Data for the study will be transcribed and entered into an electronic Case Report Form (eCRF) from the patient's medical records. The site investigator will be responsible for ensuring that all required data is collected and entered into the eCRF with the involvement of clinical research organization

研究设计

研究类型
Observational
观察模型
Case Control
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

  • •Age ≥18 years
  • •Confirmed diagnosis of CLL
  • •Patient started treatment with monotherapy acalabrutinib (prescribed by physician decision no more than 4 weeks ago before screening)
  • •Capability of providing written Informed Consent Form

排除标准

  • •Patients not corresponded to inclusion criteria
  • •Pregnancy
  • •Lactation
  • •Patients included in open-label trials
  • •Previous Bruton tyrosine kinase inhibitors (BTKI) treatment

结局指标

主要结局

• progression-free survival (rwPFS) in patients with CLL who are treated with acalabrutinib in clinical practice in Russia

时间窗: Up to 2 years

• incidence of adverse events and serious adverse events in CLL patients treated with acalabrutinib in clinical practice in Russia

时间窗: Up to 2 years

次要结局

未报告次要终点

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (14)

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