Rituximab in Combination With Fludarabine and Cyclophosphamide in Patients With Chronic Lymphocytic Leukemia
Completed
- Conditions
- Lymphocytic Leukemia, Chronic, Chronic Lymphocytic Leukemia, Cancer
- Interventions
- Other: No intervention
- Registration Number
- NCT02461316
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Evaluation of safety profile and tolerability of MabThera (rituximab) in combination with chemotherapy (fludarabine and cyclophosphamide) in the treatment of Chronic Lymphocytic Leukemia (CLL).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- Patients older than 18 years with diagnosed Chronic Lymphocytic Leukemia (CLL)
- CLL stages: Binet stage C (Rai III or IV), Binet stage B (Rai I and II) requiring treatment
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Exclusion Criteria
- Patients who are not eligible for rituximab treatment according to Summary of Product Characteristics (SmPC)
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Combination Treatment in Chronic Lymphocytic Leukemia (CLL) No intervention All participants receiving combination treatment in Chronic Lymphocytic Leukemia (CLL)
- Primary Outcome Measures
Name Time Method Percentage of Adverse Events (AEs) From baseline to end of study up to 18 months Percentage of Serious Adverse Events (SAEs) From baseline to end of study up to 18 months
- Secondary Outcome Measures
Name Time Method