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临床试验/NCT05140369
NCT05140369进行中(未招募)不适用

Observational Retrospective-Prospective Study on CLL Therapy Approaches in Russia.

AstraZeneca35 个研究点 分布在 2 个国家目标入组 6,000 人开始时间: 2021年10月29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
AstraZeneca
入组人数
6,000
试验地点
35
主要终点
Sex

研究概览

简要总结

This is going to be a non-interventional study (NIS). Assessment of variables will be carried out using data on patient's treatment in real-life clinical setting. Patients should be enrolled into study after evaluation of eligibility criteria by the investigator. 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.

Evaluation of efficacy and safety of any approaches used for CLL/SLL treatment is not the primary objective of this study, though there is no treatment of interest. Study procedures will comply with all the local regulatory requirements regarding AE reporting (pharmacovigilance).

It is planned to enroll approximately 6000 patients (suggested number of patients on WW~1000 pts, 1L~2750 pts, RR~2250 pts)

During the course of study's prospective part, it is planned to carry out at approximately 5 visits:

(if unscheduled visit performed - the information should be filled on nearest visit).

  • Baseline visit: ICF signing, initial patient's data input will be done retrospectively, for patients who are already monitored by investigational site.
  • Interim Visits (CRF will be filled every 6 months for therapy receiving patients and every 12 months for WW patients; if a patient transitions from WW to therapy, his/her CRF will be filled every 6 months; all patient's visits should be planned according routine practice and investigator's judgement on individual basis).
  • Final visit (data collection on 24 months after enrollment): patient's data input will be done for previously enrolled patients (data update)

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

入选标准

  • Age ≥18 years
  • Ability and willing to sign the ICF
  • Diagnosed CLL/SLL (including watch and wait stage of disease) according to Russian clinical guides

排除标准

  • Patients without CLL/SLL diagnosis
  • Age <18 years
  • Patients who refused/did not sign the ICF

结局指标

主要结局

Sex

时间窗: Baseline

Cytogenetic tests

时间窗: Up to 2 years

* TP53 gene mutation status * IGHV gene mutation status * complex karyotype * del13q status

ECOG status (0-1/≥2)

时间窗: Up to 2 years

Rai staging (0-IV)

时间窗: Up to 2 years

Date of diagnosis for CLL/SLL

时间窗: Baseline

Comorbidities

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 (35)

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