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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).
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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It is expected to recruit approximately 6000 patients with CLL/SLL regardless of treatment stage and line.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Belgorod | Russia | ||||
| Research Site |
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.
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.
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.
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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, Relapse/no Response ~2250 pts)
| 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 |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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