A Non-Interventional, Observational Phase IV Study to Evaluate Safety of Rituximab (Mabthera®) in Combination With Chemotherapy in Patients Treated With CD20+ Β Chronic Lymphocytic Leukemia
Overview
- Phase
- Not Applicable
- Intervention
- Rituximab
- Conditions
- Lymphocytic Leukemia, Chronic
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 67
- Locations
- 9
- Primary Endpoint
- Percentage of Participants With Adverse Events (AEs)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This observational study will evaluate the safety and efficacy of rituximab in combination with chemotherapy in first- and second-line treatment of participants with cluster of differentiation 20 (CD20)-positive B-cell chronic lymphocytic leukemia. Data will be collected from eligible participants receiving rituximab according to the Summary of Product Characteristics (SPC) during 6 months of treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants with CD20-positive B-cell chronic lymphocytic leukemia eligible for first-line or second-line therapy according to the approved SPC
Exclusion Criteria
- •Contraindications to rituximab therapy according to the approved SPC
Arms & Interventions
Rituximab
Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to SPC and routine clinical practice will be observed for 24 months.
Intervention: Rituximab
Outcomes
Primary Outcomes
Percentage of Participants With Adverse Events (AEs)
Time Frame: Baseline up to 24 months
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Secondary Outcomes
- Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards(Months 6, 12, 18, and 24)
- Percentage of Participants With CR Assessed Using Local Standards(Months 6, 12, 18, and 24)
- Progression-Free Survival (PFS) Assessed Using Local Standards(From enrollment until disease progression or death, assessed up to 24 months)
- Percentage of Participants With Disease Progression or Death Assessed Using Local Standards(Months 6, 12, 18, and 24)
- Percentage of Participants With PR Assessed Using Local Standards(Months 6, 12, 18, and 24)
- Time to Progression (TTP) Assessed Using Local Standards(From enrollment until disease progression or death, assessed up to 26 months)