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This study seeks to assess the effectiveness and safety of venetoclax in patients with relapsed and refractory chronic lymphocytic leukemia (CLL) in a real-world setting across clinical practice in the Russian Federation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax | Participants in this observational study will receive treatment with venetoclax for up to 24 months for treatment of relapsed or refractory CLL. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | tablet;oral |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) 12 Months after Treatment Initiation | ORR is defined as the percentage of participants who reach either complete remission (CR), CR with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) to treatment. | Up to approximately 12 months after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) 24 Months after Treatment Initiation | ORR is defined as the percentage of participants who reach either complete remission (CR), CR with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) to treatment. | Up to approximately 24 months after treatment initiation |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with relapsed or refractory CLL in a real-world clinical practice setting.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Dispensary #2 /ID# 215831 | Sochi | Krasnodarskiy Kray | 354057 | Russia | ||
| Moscow State budget healthcare /ID# 212875 |
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| Time to First Response to Treatment |
The time to response to treatment is defined by the time between the date of the first venetoclax intake and the date of the first assessment having documented a response (CR, CRi, nPR, and PR). |
| Up to approximately 24 months |
| Time to Best Response to Treatment | The time to best response to treatment is defined by the time between the date of the first venetoclax intake and the date of the best response documented (CR, CRi, nPR, and PR). | Up to approximately 24 months |
| Duration of Response (DoR) | DoR defined as the number of days from the date of first response (CR, CRi, nPR, or PR) to the date of disease progression or death from any cause, whichever comes first. | Up to approximately 24 months |
| Time To Next Treatment | The time to next treatment is defined as the time between the date of the first venetoclax intake and the date of the first next treatment intake after venetoclax discontinuation. | Up to approximately 24 months |
| Percentage of Patients with Undetectable Minimal Residual Disease (MRD) | Patients will be defined as having a clinical remission in the absence of MRD when they have blood or marrow with less than one CLL cell per 10000 leucocytes. | Up to approximately 24 months |
| Overall Survival (OS) Rate | OS is defined as number of days from the date of first dose to the date of the observational period end or death for all dosed patients. | Up to approximately 24 months |
| Progression-free Survival (PFS) | Progression-free survival is defined as the interval between the first treatment day to the first sign of disease progression or death from any cause | Up to approximately 24 months |
| Change from Baseline in RAND Short Form (SF)-36 Questionnaire | Patient quality of life was measured by the RAND-36 health-related quality of life (HRQoL) survey instrument. This questionnaire is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. | Up to approximately 24 months |
| Moscow |
| Moscow |
| 125284 |
| Russia |
| Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 215830 | Moscow | Moscow Oblast | 129110 | Russia |
| Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 212368 | Saint Petersburg | Sankt-Peterburg | 197101 | Russia |
| Central City Hospital #7 /ID# 212373 | Yekaterinburg | Sverdlovsk Oblast | 620137 | Russia |
| Regional Children's Clinical Hospital of Volgograd /ID# 212366 | Volgograd | Volgograd Oblast | 400138 | Russia |
| Krai Clinical Hospital /ID# 224952 | Barnaul | 656024 | Russia |
| GBUZ Regional Cancer center /ID# 216871 | Irkutsk | 664032 | Russia |
| Krai Clinical Hospital #1 /ID# 212367 | Khabarovsk | 680009 | Russia |
| Kirov Regional Clinical Hospital /ID# 217579 | Kirov | 610027 | Russia |
| Policlinic #2 /ID# 214778 | Oryol | 302040 | Russia |
| Clinical Medico-Sanitary Unit #1 /ID# 212364 | Perm | 614077 | Russia |
| Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 212372 | Saint Petersburg | 191024 | Russia |
| Almazov National Medical Research Centre /ID# 212365 | Saint Petersburg | 197341 | Russia |
| Komi Republican Oncology Dispensary /ID# 212370 | Syktyvkar | 167904 | Russia |
| City Clinical Hospital # 5 /ID# 212369 | Vladimir | 600031 | Russia |
| Regional Clinical Hospital of Vologda /ID# 212471 | Vologda | 160002 | Russia |
| Republican Hospital #1 - National Center of Medicine of Sakha (Yakutia) /ID# 212371 | Yakutsk | 677008 | Russia |
| Sverdlovsk Regional Clinical Hospital #1 /ID# 214777 | Yekaterinburg | 620102 | Russia |
| Sakhalin Regional Clinical Hospital /ID# 222503 | Yuzhno-Sakhalinsk | 693004 | Russia |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| 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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| ID | Term |
|---|---|
| C579720 | venetoclax |
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