A Study on Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)

Disease progression was defined as the occurrence of at least one of the following: \>/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes.

Time frame: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)

Population: Analysis was performed on EAS.

PFS was defined as the time from initiation of treatment with rituximab in combination with chemotherapy to disease progression or death due to any cause, whichever occurred first. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (\>/=) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes. Participants without disease progression or death at the time of analysis were censored at the last date of tumor evaluation in terms of PFS.

Time frame: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)

Population: Analysis was performed on EAS.

Time frame: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)

Population: Analysis was performed on EAS. Overall number of participants analyzed=participants analyzed for this outcome. Here, number analyzed=participants evaluable at specified time-point.

The chemotherapeutic regimen administereted during the course of study were: Rituximab-Bendamustine (R-Benda), Rituximab-Fludarabine-Cyclophosphamide (R-FC), Rituximab-Clorambucil (R-Clb), R-Other and Rituximab mono.

Time frame: Baseline, Cycle 1, 2, 3, 4, 5, 6, 7, 8, last Cycle (Cycle 18) (each cycle=1 month)

Population: Analysis was performed on EAS.

Response to treatment was assessed as per clinical routine. BOR included complete response(CR or CR with incomplete hematopoietic regeneration),partial response(PR or nodular PR),stable disease(SD),progressive disease(PD). CR:hemoglobin\>/=11 grams/deciliter(g/dL), lymphocytes\<4000 cells/cubic millimeter(cells/mm\^3), neutrophils\>5000 cells/mm\^3,platelets\>100,000 cells/mm\^3,bone marrow biopsy with \<30% lymphocytes with no lymphocytic infiltrates, no evidence of lymphoid nodules on physical exam, performance status of 0. PR:\>50% decrease in size of enlarged lymph nodes, hepatomegaly, splenomegaly, with peripheral counts meeting same criteria as CR or \>/=50% improvement from pre-treatment values.PD:occurrence of at least one of following: \>/=50% increase in longest diameter of at least 2 enlarged lymph nodes, increase in spleen and liver size by at least 2 cm from Baseline, or \>/=50% increase in number of circulating lymphocytes. Participants without CR/PR or PD were considered having SD.

Time frame: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)

Population: Analysis was performed on EAS.

B-symptoms included fever, night sweats, weight loss.

Time frame: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)

Population: Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point.

ECOG performance status was measured on a 4 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair \>50% of waking hours.

Time frame: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)

Population: Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point.

General symptoms included fatigue, reduced performance, frequent infections, abdominal pain and exhaustion.

Time frame: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)

Population: Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point.

Performance status was reflected by the Karnofsky index. Karnofsky performance status index ranges from 0-100% with higher scores indicating better functional status. An index between 90% and 100% corresponds to ECOG grade 0, index between 70% and 80% corresponds to ECOG grade 1, index between 50% and 60% corresponds to ECOG grade 2, index 40% corresponds to ECOG grade 3. ECOG grade 0=Fully active, able to carry on all pre-disease activities without restriction; grade 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; grade 2=Ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; grade 3=Capable of only limited self-care, confined to bed/chair \>50% of waking hours.

Time frame: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)

Population: Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point.

Percentage of participants with an event (progression or death) was reported. Disease progression was defined as the occurrence of at least one of the following: \>/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes.

Time frame: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)

Population: Analysis was performed on EAS with events.