Recurrent or Refractory PTCL Clinical Trial
Official title:
Phase I/II Clinical Study of Forodesine in Japanese Recurrent/Refractory Peripheral T-cell Lymphoma Patients
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).
n/a