CLL registry: CLL Therapy Approaches in Russia

AstraZeneca (Industry)
Overall Status
Recruiting ID

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).

  • 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 month, all patient's visits should be planned according routine practice and investigator's judgement on individual basis).

  • 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

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Time Perspective:
    Official Title:
    Observational Retrospective-Prospective Study on CLL Therapy Approaches in Russia.
    Actual Study Start Date :
    Oct 29, 2021
    Anticipated Primary Completion Date :
    Oct 31, 2024
    Anticipated Study Completion Date :
    Oct 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Sex [Baseline]

    2. Date of diagnosis for CLL/SLL [Baseline]

    3. Comorbidities [Up to 2 years]

    4. ECOG status (0-1/≥2) [Up to 2 years]

    5. Rai staging (0-IV) [Up to 2 years]

    6. Cytogenetic tests [Up to 2 years]

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

    Eligibility Criteria


    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • Age ≥18 years

    • Ability and willing to sign the ICF

    • Confirmed diagnosis of CLL/SLL

    Exclusion Criteria:
    • Participation in a clinical study with any investigational product during the last 4 weeks

    • Absence of data essential to obtain all necessary information

    • Age <18 years

    • Patients who refused/did not sign the ICF

    Contacts and 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


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    AstraZeneca Identifier:
    Other Study ID Numbers:
    • D8220R00038
    First Posted:
    Dec 1, 2021
    Last Update Posted:
    Aug 11, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Keywords provided by AstraZeneca
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 11, 2022