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Recurrent or Refractory PTCL clinical trials

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NCT ID: NCT01776411 Completed - Clinical trials for Recurrent or Refractory PTCL

Phase I/II Clinical Study of Forodesine in Japanese Recurrent/Refractory Peripheral T-cell Lymphoma Patients

Start date: January 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Phase I portion: To confirm safety and tolerability in recurrent/refractory peripheral T-cell lymphoma patients during repeated oral administration of forodesine 300 mg twice daily (600 mg/day) for 28 days, and determine the recommended dose. Also, to evaluate pharmacokinetics. Phase II portion: To evaluate the efficacy, safety, and pharmacokinetics of the recommended dosage regimen determined in the phase I portion. The primary efficacy endpoint shall be objective response rate (ORR).