Treatment-naive , physically fit patients ( aged 30-81 years ) with CD20-positive chronic lymphocytic leukaemia were randomly assigned in a one-to-one ratio to receive six courses of intravenous fludarabine ( 25 mg/m ( 2 ) per day ) and cyclophosphamide ( 250 mg/m ( 2 ) per day ) for the first 3 days of each 28-day treatment course with or without rituximab ( 375 mg/m ( 2 ) on day 0 of first course , and 500 mg/m ( 2 ) on day 1 of second to sixth courses ) in 190 centres in 11 countries .
