A Phase II Study to Evaluate the Efficacy and Safety 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