Study Results
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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ACTIVE_NOT_RECRUITING
6000 participants
OBSERVATIONAL
2021-10-29
2027-03-31
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Ability and willing to sign the ICF
* Diagnosed CLL/SLL (including watch and wait stage of disease) according to Russian clinical guides
Exclusion Criteria
* Age \<18 years
* Patients who refused/did not sign the ICF
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Belgorod, , Russia
Research Site
Bryansk, , Russia
Research Site
Chelyabinsk, , Russia
Research Site
Chita, , Russia
Research Site
Irkutsk, , Russia
Research Site
Kaliningrad, , Russia
Research Site
Kaluga, , Russia
Research Site
Kazan', , Russia
Research Site
Kirov, , Russia
Research Site
Krasnoyarsk, , Russia
Research Site
Kurgan, , Russia
Research Site
Mahachkala, , Russia
Research Site
Moscow, , Russia
Research Site
Nizhny Novgorod, , Russia
Research Site
Novosibirsk, , Russia
Research Site
Omsk, , Russia
Research Site
Orenburg, , Russia
Research Site
Perm, , Russia
Research Site
Petropavlovsk-Kamchatskii, , Russia
Research Site
Petrozavodsk, , Russia
Research Site
Rostov-on-Don, , Russia
Research Site
Saint-Petesburg, , Russia
Research Site
Samara, , Russia
Research Site
Saratov, , Russia
Research Site
Syktyvkar, , Russia
Research Site
Tver', , Russia
Research Site
Ufa, , Russia
Research Site
Ulan-Ude, , Russia
Research Site
Vladimir, , Russia
Research Site
Vladivostok, , Russia
Research Site
Volgograd, , Russia
Research Site
Vologda, , Russia
Research Site
Yaroslavl, , Russia
Research Site
Yekaterinburg, , Russia
Countries
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Other Identifiers
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D8220R00038
Identifier Type: -
Identifier Source: org_study_id
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