Phase I/II study of pralatrexate in Japanese patients with relapsed or refractory peripheral T-cell lymphoma.

ABSTRACT: Pralatrexate is a novel antifolate approved in the USA for the treatment of relapsed or refractory peripheral T-cell lymphoma. To assess its safety, efficacy, and pharmacokinetics in Japanese patients with this disease, we undertook a phase I/II study. Pralatrexate was given i.v. weekly for 6 weeks of a 7-week cycle. All patients received concurrent vitamin B₁₂ and folic acid. In phase I, three patients received pralatrexate 30 mg/m² and none experienced a dose-limiting toxicity. In phase II, we treated 22 additional patients with that dose. The median number of treatment cycles was 1 (range, 1-9). Nine of 20 evaluable patients (45%) achieved an objective response by central review, including two complete responses. All responses occurred within the first treatment cy

SUBMITTER: Maruyama D 

PROVIDER: S-EPMC5623731 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature