CLL Therapy Approaches in Russia

NCT ID: NCT05140369

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-29

Study Completion Date

2027-03-31

Brief Summary

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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)

Detailed Description

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Conditions

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Chronic Lymphocytic Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Belgorod, , Russia

Site Status

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Bryansk, , Russia

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Chelyabinsk, , Russia

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Chita, , Russia

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Irkutsk, , Russia

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Kaliningrad, , Russia

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Kaluga, , Russia

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Kazan', , Russia

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Kirov, , Russia

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Krasnoyarsk, , Russia

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Kurgan, , Russia

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Mahachkala, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Novosibirsk, , Russia

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Omsk, , Russia

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Orenburg, , Russia

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Perm, , Russia

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Petropavlovsk-Kamchatskii, , Russia

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Petrozavodsk, , Russia

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Rostov-on-Don, , Russia

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Saint-Petesburg, , Russia

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Samara, , Russia

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Saratov, , Russia

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Syktyvkar, , Russia

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Tver', , Russia

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Ufa, , Russia

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Ulan-Ude, , Russia

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Vladimir, , Russia

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Vladivostok, , Russia

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Volgograd, , Russia

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Vologda, , Russia

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Yaroslavl, , Russia

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Yekaterinburg, , Russia

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Countries

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Russia

Other Identifiers

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D8220R00038

Identifier Type: -

Identifier Source: org_study_id

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