A multicenter study to assess the antitumor effect and safety of fludarabine phosphate tablet (SH T 586) in combination with rituximab administered in 6 treatment cycles (1 treatment cycle: rituximab 375 mg/m2 iv on day 1 along with 5-consecutive day oral dosing of SH T 586 40 mg/m2/day from day 1 to day 5, followed by an observation period of 23 days) in patients with indolent lymphoma.

Trial Profile

A multicenter study to assess the antitumor effect and safety of fludarabine phosphate tablet (SH T 586) in combination with rituximab administered in 6 treatment cycles (1 treatment cycle: rituximab 375 mg/m2 iv on day 1 along with 5-consecutive day oral dosing of SH T 586 40 mg/m2/day from day 1 to day 5, followed by an observation period of 23 days) in patients with indolent lymphoma.

Completed
Phase of Trial: Phase II

Latest Information Update: 06 Mar 2013

At a glance

  • Drugs Fludarabine (Primary) ; Rituximab
  • Indications Non-Hodgkin's lymphoma
  • Focus Therapeutic Use
  • Sponsors Bayer; Bayer HealthCare Pharmaceuticals
  • Most Recent Events

    • 07 Jul 2009 Actual patient number (21) added as reported by ClinicalTrials.gov.
    • 17 Nov 2008 Actual end date added; patient inclusions and exclusions updated.
    • 17 Nov 2008 Status changed from active, no longer recruiting to completed.
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