A Study to Assess Effectiveness of Venclexta (Venetoclax) in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia in Routine Clinical Practice in Russian Federation

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Multi-Center Observational Study to Assess Effectiveness of Venclexta (Venetoclax) in Population of Relapse or Refractory Chronic Lymphocytic Leukemia Patients in Routine Clinical Practice in Russian Federation (FORTE)

Conditions
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Chronic Lymphocytic Leukemia (CLL), Cancer

Intervention / Treatment
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* Drug: Venetoclax


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a confirmed diagnosis of relapsed or refractory CLL. Patient for whom the physician has decided to initiate CLL treatment with venetoclax (mono and combo therapy), or up to 4 weeks after venetoclax treatment initiation Patient voluntarily agrees to participate in this study and signs informed consent form Exclusion Criteria: Has contraindications to venetoclax as listed on the approved local label in Russian Federation. Has Richter syndrome Participated in a clinical trial with an investigative drug for CLL within 30 days prior to treatment initiation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Venetoclax<br>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. | Drug: Venetoclax<br>* tablet;oral<br>* Other names: ABT-199;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Lymphocytic Leukemia (CLL), Cancer, Observational Study, Venetoclax, Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia