A Study of Obinutuzumab Evaluating Efficacy, Safety and Cost of Disease Management in Participants With Chronic Lymphocytic Leukemia and Comorbidities
- Registration Number
- NCT02915224
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Participants with untreated CLL and comorbidities, for which the physician has already decided to use obinutuzumab in association with chlorambucil
- Participation in another clinical trial during the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Obinutuzumab Obinutuzumab Participants will receive obinutuzumab as per Summary of Product Characteristics in daily practice along with chlorambucil for 24 months. Obinutuzumab Chlorambucil Participants will receive obinutuzumab as per Summary of Product Characteristics in daily practice along with chlorambucil for 24 months.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS)\n From screening every 6 months to Month 18 until disease progression (up to 24 months)
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) 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 Response 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 Next Treatment, Defined as the Time Between the Date of Enrollment and First Intake of New Anti-Leukemic Therapy Baseline up to 24 months Percentage of Participants With Dose Delays/Discontinuations 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 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 Particular Interest Baseline up to 24 months Number of Diagnostic and Lab Exams Baseline up to 24 months Percentage of Participants With Protocol Defined Adverse Events of Special Interest Baseline up to 24 months Percentage of Participants With Non-hematological Toxicities Baseline up to 24 months Number of Physician Visits Baseline up to 24 months Percentage of Participants With Hematological Toxicities Baseline up to 24 Months Number of Hospital Admissions Baseline up to 24 months
Trial Locations
- Locations (11)
Attiko Hospital; Haematology Clinic
🇬🇷Athens, Greece
General Hospital G. Papanikolaou; Hematology, BMT Unit
🇬🇷Thessaloniki, Greece
AXEPA Pathology Section; A Pathology Clinic
🇬🇷Thessaloniki, Greece
University General Hospital of Patra; Internal Medicine Clinic - Hematology Department
🇬🇷Patra, Greece
Metaxa Hospital; Hematology Clinic
🇬🇷Peiraias, Greece
Laiko General Hospital; Hematology Clinic
🇬🇷Athens, Greece
General Hospital G. Gennimatas; Hematology Dept.
🇬🇷Athens, Greece
University Hospital of Larissa; Hematology Dept.
🇬🇷Larissa, Greece
University General Hospital of Alexandroupolis; Haemotology
🇬🇷Alexandroup, Greece
Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
🇬🇷Athens, Greece
Periph. University General Hospital of Heraklion; Hematology
🇬🇷Heraklion, Greece