Observational Study: Safety and Effectiveness of Obinutuzumab in Chronic Lymphocytic Leukemia in Argentina

Study Overview
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Brief Summary
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This observational study aims to study the effectiveness and safety of Obinutuzumab in common clinical practice settings in Argentina. The study population comprises all patients with chronic lymphocytic leukemia (CLL) that have received the indication for treatment with Obinutuzumab as per routine clinical practice.

Official Title
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An Observational Study of the Safety and Effectiveness of Obinutuzumab in Patients With Chronic Lymphocytic Leukemia Treated in Argentina

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Biological: Obinutuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have received at least one dose of Obinutuzumab as per local label and clinical practice. Exclusion Criteria: Included in clinical trial

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>All participants with chronic lymphocytic leukemia (CLL) who have received the indication for treatment with Obinutuzumab, as per routine clinical practice in Argentina. | Biological: Obinutuzumab<br>* Obinutuzumab will be administered as intravenous infusion for 6 cycles (28 days per cycle): 100 milligrams (mg) on day 1 Cycle 1, 900 mg on day 2 Cycle 1, 1000 mg on days 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2-6.<br>* Other names: Gazyva®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | Overall response rate was defined as percentage of participants with complete response (CR) or partial response (PR). CR was defined as peripheral blood lymphocytes below 4 x 10^9/liter (L), absence of significant lymphadenopathy, no hepatomegaly, no splenomegaly, absence of disease or B symptoms, neutrophils >1.5 x 10^9/L, platelets >100 x 10^9/L, hemoglobin >11 grams/deciliter (g/dl) and bone marrow at least normocellular for age. PR was defined as >=50% decrease in peripheral blood lymphocyte count, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver enlargement and/or >/=50% reduction of spleen enlargement, plus at least one of the following: neutrophils >1.5 x 10^9/L or >/=50% increase, or platelets >100 x 10^9/L or ≥50% increase, or hemoglobin 11 g/dl or >/=50% increase. Overall response rate = CR + PR | Up to 2 months after completion of 6 treatment cycles (up to approximately 8 months) | 
| Percentage of Participants With Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Response Rate | CR was defined as peripheral blood lymphocytes below 4 x 10^9/liter (L), absence of significant lymphadenopathy, no hepatomegaly, no splenomegaly, absence of disease or B symptoms, neutrophils >1.5 x 10^9/L, platelets >100 x 10^9/L, hemoglobin 11 g/dl and bone marrow at least normocellular for age. | Up to 2 months after completion of 6 treatment cycles (up to approximately 8 months) | 
| Partial Response Rate | PR was defined as >=50% decrease in peripheral blood lymphocyte count from the pre-treatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver enlargement and/or >/=50% reduction of spleen enlargement, plus at least one of the following: neutrophils >1.5 x 10^9/L or >/=50% increase, or platelets >100 x 10^9/L or ≥50% increase, or hemoglobin 11 g/dl or >/=50% increase. | Up to 2 months after completion of 6 treatment cycles (up to approximately 8 months) | 
| Progression-free Survival (PFS) | PFS is defined as the time from the first dose of treatment to the first occurrence of progression, or death from any cause as assessed by the physician. Progressive disease is defined by any of the following: >/=50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, >/=50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, >/=50% increase in the enlargement of the liver and/or spleen, transformation to a more aggressive histology, after treatment, the progression of any cytopenia (a decrease of hemoglobin levels >2 g/dL or <10 g/dL or a decrease of platelet counts >50% or <100 x 10x9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L), excluding immune causes. | After the completion of treatment, at 12 and 24 months after start of treatment | 
| Median Duration of Response | Duration of response is defined as the time from the date the response (either CR or PR) was first recorded until the date of disease progression or death due to any cause. Disease progression is defined by any of the following: >/=50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, >/=50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, >/=50% increase in the enlargement of the liver and/or spleen, transformation to a more aggressive histology, after treatment, the progression of any cytopenia (a decrease of hemoglobin levels >2 g/dL or <10 g/dL or a decrease of platelet counts >50% or <100 x 10x9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L), excluding immune causes. | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLL, obinutuzumab, treatment