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

Genzyme

Status and phase

Completed

Phase 2

Conditions

Non Hodgkin Lymphoma

Treatments

Drug: Fludarabine Phosphate (Fludara)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00185445

308580

91381

Details and patient eligibility

About

The purpose of the study is to demonstrate that oral fludarabine phosphate is comparable to i.v. formulation used in combination with mitoxantrone in terms of efficacy, safety and risk/benefit profile

Full description

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.

Enrollment

62 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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