Observational study on chronic lymphocytic leukemia treatment in Russia
Observational Retrospective-Prospective Study on CLL Therapy Approaches in Russia.
AstraZeneca · NCT05140369
This study is looking to gather information on how chronic lymphocytic leukemia is treated in Russia by observing around 6000 patients during their regular doctor visits.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca (industry) |
| Locations | 38 sites (Belgorod and 37 other locations) |
| Trial ID | NCT05140369 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world data on the treatment approaches for chronic lymphocytic leukemia (CLL) in Russia. It will enroll approximately 6000 patients who meet specific eligibility criteria, with data collected during routine clinical visits without any additional interventions. The study will assess treatment assignment based on current clinical practices and will comply with local regulatory requirements for adverse event reporting. The primary objective is not to evaluate the efficacy or safety of specific treatments but to document the treatment landscape for CLL in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma.
Not a fit: Patients under 18 years old or those without a diagnosis of CLL/SLL will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of current CLL treatment practices in Russia, potentially guiding future treatment strategies.
How similar studies have performed: While this study is observational and does not evaluate specific treatments, similar observational studies have successfully documented treatment patterns and outcomes in other regions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Belgorod and 37 other locations
- Research site — Belgorod, Russian Federation (WITHDRAWN)
- Research site — Bryansk, Russian Federation (NOT_YET_RECRUITING)
- Research site — Buriatia, Russian Federation (RECRUITING)
- Research Site — Chelyabinsk, Russian Federation (RECRUITING)
- Research site — Chita, Russian Federation (RECRUITING)
- Research Site — Ekaterinburg, Russian Federation (RECRUITING)
- Research Site — Irkutsk, Russian Federation (ACTIVE_NOT_RECRUITING)
- Research site — Kaliningrad, Russian Federation (RECRUITING)
- Research Site — Kaluga, Russian Federation (RECRUITING)
- Research Site — Kazan, Russian Federation (RECRUITING)
- Research Site — Kazan, Russian Federation (NOT_YET_RECRUITING)
- Research Site — Kirov, Russian Federation (RECRUITING)
- Research Site — Krasnoyarsk, Russian Federation (RECRUITING)
- Research Site — Kurgan, Russian Federation (RECRUITING)
- Research site — Mahachkala, Russian Federation (NOT_YET_RECRUITING)
- Research Site — Moscow, Russian Federation (RECRUITING)
- Research site — Moscow, Russian Federation (ACTIVE_NOT_RECRUITING)
- Research Site — Nizhniy Novgorod, Russian Federation (RECRUITING)
- Research Site — Novosibirsk, Russian Federation (RECRUITING)
- Research site — Omsk, Russian Federation (RECRUITING)
- Research site — Orenburg, Russian Federation (RECRUITING)
- Research site — Perm, Russian Federation (NOT_YET_RECRUITING)
- Research site — Petropavlovsk-Kamchtskiy, Russian Federation (NOT_YET_RECRUITING)
- Research Site — Petrozavodsk, Russian Federation (RECRUITING)
- Research Site — Rostov on Don, Russian Federation (RECRUITING)
- Research Site — Saint Petersburg, Russian Federation (RECRUITING)
- Research site — Saint Petersburg, Russian Federation (NOT_YET_RECRUITING)
- Research Site — Samara, Russian Federation (RECRUITING)
- Research Site — Saratov, Russian Federation (RECRUITING)
- Research Site — Syktyvkar, Russian Federation (RECRUITING)
- Research site — Tver, Russian Federation (RECRUITING)
- Research Site — Ufa, Russian Federation (RECRUITING)
- Research site — Ulan-Ude, Russian Federation (RECRUITING)
- Research site — Vladimir, Russian Federation (RECRUITING)
- Research site — Vladivostok, Russian Federation (RECRUITING)
- Research Site — Volgograd, Russian Federation (RECRUITING)
- Research site — Vologda, Russian Federation (RECRUITING)
- Research Site — Yaroslavl, Russian Federation (RECRUITING)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Lymphocytic Leukemia, Chronic lymphocytic leukemia