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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Best overall response rate; Antitumor effect
at screening and re-evaluation, at 4th week or at the time of discontinuation of treatment cycles 1, 3 and 6, and at 12th week after last observation of last treatment cycle
Japan: Pharmaceuticals and Medical Devices Agency