Peripheral T-cell Lymphoma Clinical Trial
Official title:
Phase I/II Clinical Study of Pralatrexate in Japanese Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Phase I portion:
To evaluate the safety and tolerability of pralatrexate with concurrent vitamin B12 and folic
acid supplementation in Japanese patients with relapsed or refractory PTCL and to determine
the recommended dosage. 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
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