Skip to content

CLL Therapy Approaches in Russia

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05140369
Acronym
CLL registry
Enrollment
6000
Registered
2021-12-01
Start date
2021-10-29
Completion date
2027-03-31
Last updated
2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic lymphocytic leukemia

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)

Interventions

None listed

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SexBaseline
Date of diagnosis for CLL/SLLBaseline
ComorbiditiesUp to 2 years
ECOG status (0-1/≥2)Up to 2 years
Rai staging (0-IV)Up to 2 years
Cytogenetic testsUp to 2 years* TP53 gene mutation status * IGHV gene mutation status * complex karyotype * del13q status

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026