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