Chronic Lymphocytic Leukemia
Conditions
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.
Interventions
DRUGChlorambucil
Participants will receive chlorambucil as per summary of product characteristics in daily practice. Protocol does not specify any dosage.
DRUGObinutuzumab
Participants will receive obinutuzumab as per summary of product characteristics in daily practice. Protocol does not specify any dosage.
Sponsors
Hoffmann-La Roche
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS)\n | From screening every 6 months to Month 18 until disease progression (up to 24 months) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Overall Survival (OS) | From screening every 6 months to Month 18 until disease progression (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 |
| Percentage of Participants With Dose Delays/Discontinuations | Baseline up to 24 months |
Countries
Greece
Outcome results
None listed