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