A Study of Obinutuzumab Evaluating Efficacy, Safety and Cost of Disease Management in Participants With Chronic Lymphocytic Leukemia and Comorbidities

Study Overview
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Brief Summary
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This multicenter, single arm, non-interventional, observational study will evaluate the efficacy and safety of obinutuzumab in daily clinical practice in participants with chronic lymphocytic leukemia (CLL). The study will also assess cost of disease management. The total length of the study is 42 months.

Official Title
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A Multicenter, Single Arm, Non-Interventional, Observational Study of Obinutuzumab to Evaluate Efficacy, Safety and Cost of Disease Management in Patients With Chronic Lymphocytic Leukemia and Comorbidities in Greece

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Chlorambucil
* Drug: Obinutuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with untreated CLL and comorbidities, for which the physician has already decided to use obinutuzumab in association with chlorambucil Exclusion Criteria: Participation in another clinical trial during the study

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 |
| --- | --- |
| Obinutuzumab<br>Participants will receive obinutuzumab as per Summary of Product Characteristics in daily practice along with chlorambucil for 24 months. | Drug: Chlorambucil<br>* Participants will receive chlorambucil as per summary of product characteristics in daily practice. Protocol does not specify any dosage.<br>Drug: Obinutuzumab<br>* Participants will receive obinutuzumab as per summary of product characteristics in daily practice. Protocol does not specify any dosage.<br>* Other names: Gazyvaro®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS)\n |  | From screening every 6 months to Month 18 until disease progression (up to 24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | From screening every 6 months to Month 18 until disease progression (up to 24 months) | 
| Percentage of Participants With Overall Response as Assessed by Investigator |  | From screening every 6 months to Month 18 until disease progression (up to 24 months) | 
| Time to Response |  | From screening every 6 months to Month 18 until disease progression (up to 24 months) | 
| Percentage of Participants With Best Overall Response as Assessed by Investigator |  | From screening every 6 months to Month 18 until disease progression (up to 24 months) | 
| Time to Next Treatment, Defined as the Time Between the Date of Enrollment and First Intake of New Anti-Leukemic Therapy |  | Baseline up to 24 months | 
| Duration of Response |  | From screening every 6 months to Month 18 until disease progression (up to 24 months) | 
| Percentage of Participants With Protocol Defined Adverse Events of Special Interest |  | Baseline up to 24 months | 
| Percentage of Participants With Protocol Defined Adverse Events of Particular Interest |  | Baseline up to 24 months | 
| Percentage of Participants With Dose Delays/Discontinuations |  | Baseline up to 24 months | 
| Percentage of Participants With Hematological Toxicities |  | Baseline up to 24 Months | 
| Percentage of Participants With Non-hematological Toxicities |  | Baseline up to 24 months | 
| Number of Hospital Admissions |  | Baseline up to 24 months | 
| Number of Physician Visits |  | Baseline up to 24 months | 
| Number of Diagnostic and Lab Exams |  | Baseline up to 24 months | 
| Number of Medical Procedures (Blood Transfusions, Bone Marrow, or Stem Cell Transplantation) |  | Baseline up to 24 months | 
| Costs of Treatment With Obinutuzumab |  | Baseline up to 24 months |