Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genzyme, a Sanofi Company
As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Efficacy and Safety Study of Oral Fludarabine Phosphate in Combination With Mitoxantrone as First Line Treatment in Follicular NHL
