CLL Therapy Approaches in Russia (CLL registry)

AstraZeneca

Status: Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia

Study type: Observational

Funder types: Industry

Identifiers

NCT05140369

D8220R00038

Details and patient eligibility

About

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)

Enrollment: 6,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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