NCT00688883

Fludara (Oral) Phase II Study for Indolent Lymphoma

A Multicenter, Open Study to Assess the Antitumor Effect and Safety of Oral Fludarabine Phosphate (Fludara (SH T 586): 40 mg/m2/Day) Administered in 3 - 6 Treatment Cycles (1 Treatment Cycle: 5-consecutive Day Dosing, Followed by a Observation Period of 23 Days) in Patients With Indolent Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

To assess the antitumor effect and safety of Fludara in patients with indolent lymphoma.

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	Fludarabine Phosphate (Fludara)	Patients received Fludarabine Phosphate orally for 5 consecutive days, followed by a 23-day observation period. Setting this as 1 treatment cycle, 6 cycles will be given.

Timeline

• Start date: 2003-02-01
• Primary completion: 2004-08-01
• Completion: 2004-08-01
• First posted: 2008-06-03
• Last updated: 2013-12-04

Locations

17 sites across 1 country: Japan