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.
Study Type
OBSERVATIONAL
Enrollment
50
Participants will receive chlorambucil as per summary of product characteristics in daily practice. Protocol does not specify any dosage.
Participants will receive obinutuzumab as per summary of product characteristics in daily practice. Protocol does not specify any dosage.
University General Hospital of Alexandroupolis; Haemotology
Alexandroup, Greece
Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
Athens, Greece
Laiko General Hospital; Hematology Clinic
Athens, Greece
Progression Free Survival (PFS)\n
Time frame: From screening every 6 months to Month 18 until disease progression (up to 24 months)
Overall Survival (OS)
Time frame: 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
Time frame: From screening every 6 months to Month 18 until disease progression (up to 24 months)
Time to Response
Time frame: 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
Time frame: 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
Time frame: Baseline up to 24 months
Duration of Response
Time frame: 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
Time frame: Baseline up to 24 months
Percentage of Participants With Protocol Defined Adverse Events of Particular Interest
Time frame: Baseline up to 24 months
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General Hospital G. Gennimatas; Hematology Dept.
Athens, Greece
Attiko Hospital; Haematology Clinic
Athens, Greece
Periph. University General Hospital of Heraklion; Hematology
Heraklion, Greece
University Hospital of Larissa; Hematology Dept.
Larissa, Greece
University General Hospital of Patra; Internal Medicine Clinic - Hematology Department
Pátrai, Greece
Metaxa Hospital; Hematology Clinic
Piraeus, Greece
AXEPA Pathology Section; A Pathology Clinic
Thessaloniki, Greece
...and 1 more locations
Percentage of Participants With Dose Delays/Discontinuations
Time frame: Baseline up to 24 months
Percentage of Participants With Hematological Toxicities
Time frame: Baseline up to 24 Months
Percentage of Participants With Non-hematological Toxicities
Time frame: Baseline up to 24 months
Number of Hospital Admissions
Time frame: Baseline up to 24 months
Number of Physician Visits
Time frame: Baseline up to 24 months
Number of Diagnostic and Lab Exams
Time frame: Baseline up to 24 months
Number of Medical Procedures (Blood Transfusions, Bone Marrow, or Stem Cell Transplantation)
Time frame: Baseline up to 24 months
Costs of Treatment With Obinutuzumab
Time frame: Baseline up to 24 months