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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obinutuzumab | Participants will receive obinutuzumab as per Summary of Product Characteristics in daily practice along with chlorambucil for 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorambucil | Drug | Participants will receive chlorambucil as per summary of product characteristics in daily practice. Protocol does not specify any dosage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS)\n | From screening every 6 months to Month 18 until disease progression (up to 24 months) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants receiving obinutuzumab for CLL and comorbidities
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University General Hospital of Alexandroupolis; Haemotology | Alexandroup | 068100 | Greece | |||
| Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine |
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| Obinutuzumab | Drug | Participants will receive obinutuzumab as per summary of product characteristics in daily practice. Protocol does not specify any dosage. |
|
|
| 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 |
| Athens |
| 115 27 |
| Greece |
| Laiko General Hospital; Hematology Clinic | Athens | 115 27 | Greece |
| General Hospital G. Gennimatas; Hematology Dept. | Athens | 11527 | Greece |
| Attiko Hospital; Haematology Clinic | Athens | 124 62 | Greece |
| Periph. University General Hospital of Heraklion; Hematology | Heraklion | 711 10 | Greece |
| University Hospital of Larissa; Hematology Dept. | Larissa | 411100 | Greece |
| University General Hospital of Patra; Internal Medicine Clinic - Hematology Department | Pátrai | 26504 | Greece |
| Metaxa Hospital; Hematology Clinic | Piraeus | 18537 | Greece |
| AXEPA Pathology Section; A Pathology Clinic | Thessaloniki | 54636 | Greece |
| General Hospital G. Papanikolaou; Hematology, BMT Unit | Thessaloniki | 570 10 | Greece |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| 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 |
|---|---|
| D002699 | Chlorambucil |
| C543332 | obinutuzumab |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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