Efficacy and Safety Study of Oral Fludarabine Phosphate in Combination With Mitoxantrone as First Line Treatment in Follicular NHL

Inclusion Criteria: * Indolent B-cell follicular non-Hodgkin's lymphoma (grade I-II according to REAL classification) * Stage II to IV according to Ann Arbor staging system * WHO performance status grade 0, 1 or 2 and life expectancy of greater than 6 months Exclusion Criteria: * Patients who have received any previous treatment for follicular NHL * Patients with severe or life-threatening cardiac, pulmonary, neurological, psychiatric or metabolic disease * Pregnant and lactating women * Women of childbearing potential, and all men, not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy * Laboratory screens positive for Hepatitis B, C or HIV infections * Patients with autoimmune thrombocytopenia or hemolytic anemia with clinical evidence. NB. A positive Coombs test alone (with no clinical evidence of hemolysis) would not preclude entry in the study. * Histological transformation to aggressive B-cell lymphoma * Patients with prior malignancies except non melanoma skin tumors or stage 0 (in situ) cervical carcinoma * Impairment of hepatic function unless disease related indicated by bilirubin, ASAT, ALAT or gamma-GT raised 2 times above the upper limit of the local laboratory range * Impairment of renal function indicated by serum creatinine \< 30 ml/min * Patients who require systemic long-term therapy with glucocorticoids * Participation at the same time in another study in which investigational drugs are used * Patients unable to regularly attend outpatient clinic for treatment and assessments * Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent * Patients with active infection