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Clinical Trials/NCT05140369
NCT05140369
Active, not recruiting
Not Applicable

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

AstraZeneca1 site in 1 country6,000 target enrollmentOctober 29, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Lymphocytic Leukemia
Sponsor
AstraZeneca
Enrollment
6000
Locations
1
Primary Endpoint
Sex
Status
Active, not recruiting
Last Updated
3 months ago

Overview

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 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)
Registry
clinicaltrials.gov
Start Date
October 29, 2021
End Date
March 31, 2027
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Sex

Time Frame: Baseline

Cytogenetic tests

Time Frame: Up to 2 years

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

ECOG status (0-1/≥2)

Time Frame: Up to 2 years

Rai staging (0-IV)

Time Frame: Up to 2 years

Date of diagnosis for CLL/SLL

Time Frame: Baseline

Comorbidities

Time Frame: Up to 2 years

Study Sites (1)

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