Rituximab in Combination With Fludarabine and Cyclophosphamide in Patients With Chronic Lymphocytic Leukemia

Hoffmann-La Roche22 enrolled

Overview

Evaluation of safety profile and tolerability of MabThera (rituximab) in combination with chemotherapy (fludarabine and cyclophosphamide) in the treatment of Chronic Lymphocytic Leukemia (CLL).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lymphocytic Leukemia, Chronic, Chronic Lymphocytic Leukemia, Cancer

Interventions

No interventionOTHER

No intervention administered in this study: Rituximab in combination with fludarabine and cyclophosphamide for 6 months according to registered indication.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: \- Patients who are not eligible for rituximab treatment according to Summary of Product Characteristics (SmPC)

Locations (3)

Unnamed facility

Belgrade, Serbia

Unnamed facility

Kragujevac, Serbia

Unnamed facility

Novi Sad, Serbia

Outcomes

Primary Outcomes

Percentage of Adverse Events (AEs)

Time frame: From baseline to end of study up to 18 months

Percentage of Serious Adverse Events (SAEs)

Time frame: From baseline to end of study up to 18 months

Data from ClinicalTrials.gov

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