A Study of Rituximab (MabThera) in Combination With Chemotherapy in Participants With CD20-Positive B-Cell Chronic Lymphocytic Leukemia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lymphocytic Leukemia, Chronic

Intervention / Treatment
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* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rituximab<br>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. | Drug: Rituximab<br>* Rituximab will be administered in combination with chemotherapy according to SPC and routine clinical practice.<br>* Other names: MabThera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Baseline up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) Assessed Using Local Standards | PFS was defined as the time from enrollment to the first documented progression of disease or death due to any cause. Progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. KaplanMeier estimate was used for analysis. | From enrollment until disease progression or death, assessed up to 24 months | 
| Percentage of Participants With Disease Progression or Death Assessed Using Local Standards | PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | Months 6, 12, 18, and 24 | 
| Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards | Percentage of participants with CR or PR as determined by the investigator was reported. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. | Months 6, 12, 18, and 24 | 
| Percentage of Participants With CR Assessed Using Local Standards | Percentage of participants with CR as determined by the investigator was reported. CR was defined as disappearance of all target lesions. | Months 6, 12, 18, and 24 | 
| Percentage of Participants With PR Assessed Using Local Standards | Percentage of participants with PR as determined by the investigator was reported. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. | Months 6, 12, 18, and 24 | 
| Time to Progression (TTP) Assessed Using Local Standards | TTP is defined as the time from enrollment to the PD. PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Kaplan-Meier estimate was used for analysis. | From enrollment until disease progression or death, assessed up to 26 months |