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

Dai Maruyama, Hirokazu Nagai, Yoshinobu Maeda, Takahiko Nakane, Tatsu Shimoyama, Tomonori Nakazato, Rika Sakai, Takayuki Ishikawa, Koji Izutsu, Ryuzo Ueda, Kensei Tobinai

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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 cycle. At the time of data cut-off, median progression-free survival was 150 days. Median overall survival was not reached. In the total population, the most commonly reported adverse events included mucositis (88%), thrombocytopenia (68%), liver function test abnormality (64%), anemia (60%), and lymphopenia (56%). Grade 3/4 adverse events included lymphopenia (52%), thrombocytopenia (40%), leukopenia (28%), neutropenia (24%), anemia (20%), and mucositis (20%). The pharmacokinetic profile showed no drug accumulation with repeat dosing. These results indicate that pralatrexate is generally well tolerated and effective in Japanese patients with relapsed or refractory peripheral T-cell lymphoma. This trial was registered with ClinicalTrials.gov (NCT02013362).

Original languageEnglish
Pages (from-to)2061-2068
Number of pages8
JournalCancer Science
Volume108
Issue number10
DOIs
Publication statusPublished - Oct 2017

Keywords

  • Clinical trial
  • Japanese
  • folic acid antagonists
  • peripheral T-cell lymphoma
  • pralatrexate

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Maruyama, D., Nagai, H., Maeda, Y., Nakane, T., Shimoyama, T., Nakazato, T., Sakai, R., Ishikawa, T., Izutsu, K., Ueda, R., & Tobinai, K. (2017). Phase I/II study of pralatrexate in Japanese patients with relapsed or refractory peripheral T-cell lymphoma. Cancer Science, 108(10), 2061-2068. https://doi.org/10.1111/cas.13340