CLL Therapy Approaches in Russia
CLL registry
Observational Retrospective-Prospective Study on CLL Therapy Approaches in Russia.
1 other identifier
observational
6,000
1 country
34
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Longer than P75 for all trials
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 29, 2021
CompletedFirst Submitted
Initial submission to the registry
November 17, 2021
CompletedFirst Posted
Study publicly available on registry
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
May 14, 2026
May 1, 2026
5.4 years
November 17, 2021
May 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Sex
Baseline
Date of diagnosis for CLL/SLL
Baseline
Comorbidities
Up to 2 years
ECOG status (0-1/≥2)
Up to 2 years
Rai staging (0-IV)
Up to 2 years
Cytogenetic tests
* TP53 gene mutation status * IGHV gene mutation status * complex karyotype * del13q status
Up to 2 years
Eligibility Criteria
It is expected to recruit approximately 6000 patients with CLL/SLL regardless of treatment stage and line.
You may qualify if:
- 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
You may not qualify if:
- Patients without CLL/SLL diagnosis
- Age \<18 years
- Patients who refused/did not sign the ICF
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (34)
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
Biospecimen
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, Relapse/no Response \~2250 pts)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2021
First Posted
December 1, 2021
Study Start
October 29, 2021
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
May 14, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.