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

Phase 2

Completed

• Conditions: Non Hodgkin Lymphoma
• Interventions: Drug: Fludarabine Phosphate (Fludara)

• Registration Number: NCT00185445
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-02
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Fludarabine Phosphate (Fludara)	-

Primary Outcome Measures

Name	Time	Method
Complete response rate	Measurement of outcome 4 to 6 weeks after EOT

Secondary Outcome Measures

Name	Time	Method
Overall response rate, molecular response rate, toxicity profile, patients quality of life	Measurement of outcome 4 to 6 weeks after EOT