Chronic Lymphocytic LeukemiaCLL registryNCT05140369
CLL Therapy Approaches in Russia
An observational study of Chronic Lymphocytic Leukemia, run by AstraZeneca at 34 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- How many people
- 6,000 participants
- Where
- 34 sitesRussia
- Study dates
- 29 Oct 2021to 31 Mar 2027
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It is expected to recruit approximately 6000 patients with CLL/SLL regardless of treatment stage and line.
Who may be able to join
- 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
Who cannot join
- Patients without CLL/SLL diagnosis
- Age <18 years
- Patients who refused/did not sign the ICF
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Russia34 sites
Research Site
Belgorod
Research Site
Bryansk
Research Site
Chelyabinsk
Research Site
Chita
Research Site
Irkutsk
Research Site
Kaliningrad
Research Site
Kaluga
Research Site
Kazan'
Research Site
Kirov
Research Site
Krasnoyarsk
Research Site
Kurgan
Research Site
Mahachkala
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Novosibirsk
Research Site
Omsk
Research Site
Orenburg
Research Site
Perm
Research Site
Petropavlovsk-Kamchatskii
Research Site
Petrozavodsk
Research Site
Rostov-on-Don
Research Site
Saint-Petesburg
Research Site
Samara
Research Site
Saratov
Research Site
Syktyvkar
Research Site
Tver'
Research Site
Ufa
Research Site
Ulan-Ude
Research Site
Vladimir
Research Site
Vladivostok
Research Site
Volgograd
Research Site
Vologda
Research Site
Yaroslavl
Research Site
Yekaterinburg
About this study
Official title: Observational Retrospective-Prospective Study on 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).
Read more
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)
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic lymphocytic leukemia
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Sex
Measured: Baseline
Date of diagnosis for CLL/SLL
Measured: Baseline
Comorbidities
Measured: Up to 2 years
ECOG status (0-1/≥2)
Measured: Up to 2 years
Rai staging (0-IV)
Measured: Up to 2 years
Cytogenetic tests
- TP53 gene mutation status
- IGHV gene mutation status
- complex karyotype
- del13q status
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start29 Oct 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140369
- Sponsor's protocol ID
- D8220R00038
- Acronym
- CLL registry
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2021
- Last updated
- 3 Sep 2026
- Results posted
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective-Prospective Study on CLL Therapy Approaches in Russia.
- ClinicalTrials.gov ID
- NCT05140369
- Acronym / sponsor ID
- CLL registry / D8220R00038
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic lymphocytic leukemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is expected to recruit approximately 6000 patients with CLL/SLL regardless of treatment stage and line.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients without CLL/SLL diagnosis
- Age <18 years
- Patients who refused/did not sign the ICF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sex
Time frame: Baseline
Date of diagnosis for CLL/SLL
Time frame: Baseline
Comorbidities
Time frame: Up to 2 years
ECOG status (0-1/≥2)
Time frame: Up to 2 years
Rai staging (0-IV)
Time frame: Up to 2 years
Cytogenetic tests
Time frame: Up to 2 years
* TP53 gene mutation status * IGHV gene mutation status * complex karyotype * del13q status
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia, run by AstraZeneca at 34 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sex (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.