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.
Study Type
OBSERVATIONAL
Enrollment
67
Rituximab will be administered in combination with chemotherapy according to SPC and routine clinical practice.
University General Hospital of Alexandroupolis; Haemotology
Alexandroupoli, Greece
General Hospital of Athens Evangelismos; Hematology
Athens, Greece
Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
Athens, Greece
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.
Time frame: Baseline up to 24 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Metropolitan Hospital; Hematology Dept
Athens, Greece
Periph. University General Hospital of Heraklion; Hematology
Heraklion, Greece
University Hospital of Larissa; Hematology Dept.
Larissa, Greece
General Hospital of Patras Agios Andreas; Hematology Department
Pátrai, Greece
University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division
Pátrai, Greece
Georgios Papanikolaou Hospital; Hematology Department
Thessaloniki, Greece
Time frame: 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.
Time frame: 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.
Time frame: From enrollment until disease progression or death, assessed up to 26 months