CLL registry: CLL Therapy Approaches in Russia
Study Details
Study Description
Brief Summary
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 2000 patients. It is planned to enroll approximately 2000 patients (suggested number of patients on WW520 pts, 1L780 pts, RR~700 pts)
During the course of study's prospective part, it is planned to carry out at approximately 7 visits:
(if unscheduled visit performed - the information should be filled on nearest visit).
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Baseline visit: ICF signing, initial patient's data input will be done retrospectively, for patients who are already monitored by investigational site.
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Interim Visits (CRF will be filled every 6 month, all patient's visits should be planned according routine practice and investigator's judgement on individual basis).
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Final visit (data collection on 36 months after enrollment): patient's data input will be done for previously enrolled patients (data update).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Sex [Baseline]
- Date of diagnosis for CLL/SLL [Baseline]
- Comorbidities [Up to 2 years]
- ECOG status (0-1/≥2) [Up to 2 years]
- Rai staging (0-IV) [Up to 2 years]
- Cytogenetic tests [Up to 2 years]
TP53 gene mutation status IGHV gene mutation status complex karyotype del13q status
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years
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Ability and willing to sign the ICF
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Confirmed diagnosis of CLL/SLL
Exclusion Criteria:
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Participation in a clinical study with any investigational product during the last 4 weeks
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Absence of data essential to obtain all necessary information
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Age <18 years
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Patients who refused/did not sign the ICF
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Irkutsk | Russian Federation | ||
| 2 | Research Site | Moscow | Russian Federation | ||
| 3 | Research Site | Moscow | Russian Federation | ||
| 4 | Research Site | Nizhniy Novgorod | Russian Federation | ||
| 5 | Research Site | Novosibirsk | Russian Federation | ||
| 6 | Research Site | Saint Petersburg | Russian Federation |
Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D8220R00038