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NCT Number: NCT05140369

CLL Therapy Approaches in Russia

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Belgorod, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sex

    Time frame: Baseline

  2. Date of diagnosis for CLL/SLL

    Time frame: Baseline

  3. Comorbidities

    Time frame: Up to 2 years

  4. ECOG status (0-1/≥2)

    Time frame: Up to 2 years

  5. Rai staging (0-IV)

    Time frame: Up to 2 years

  6. Cytogenetic tests

    Time frame: Up to 2 years

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: CLL registry

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Dec 1, 2021
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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