[Rinsho ketsueki] The Japanese journal of clinical hematology · 2025
[Phase II study of glucarpidase in Japanese patients with delayed methotrexate clearance after high-dose methotrexate therapy].
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеАннотация на английскомНазвание и аннотация: Перевод в очереди
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Okada Keiko, Ogawa Chitose, Kayatani Rishu, Azuma Sakiko, Kikuchi Natsumi, Noguchi Mayuko, Tanimura Kazuki, Yamasaki Kai, Nitani Chika, Fujisaki Hiroyuki, Miyazaki Bunpei, Arakawa Ayumu, Miyairi Kazunari, Ro Tokihiro, Ogawa Atsushi
Аннотация
OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of glucarpidase in eight Japanese patients with delayed methotrexate (MTX) elimination following high-dose methotrexate therapy (HD-MTX) under near-clinical conditions.
METHODS: This was a multicenter, single-arm, open-label, phase II clinical study. Glucarpidase was administered in accordance with the criteria for delayed MTX elimination described in the package insert, and supportive care for HD-MTX was continued after glucarpidase dosing.
RESULTS: The plasma MTX concentration 48 hours after the first dose of glucarpidase decreased by at least 90% from baseline in all patients. Moreover, 87.5% of patients had plasma MTX concentrations below 1 µmol/l. Grade ≥3 adverse events were reported in 25.0% of patients, but no adverse events were found to be causally related to glucarpidase.
CONCLUSION: The results of this study are similar to those of previous clinical studies, and indicate that glucarpidase should be effective and safe in clinical practice.
METHODS: This was a multicenter, single-arm, open-label, phase II clinical study. Glucarpidase was administered in accordance with the criteria for delayed MTX elimination described in the package insert, and supportive care for HD-MTX was continued after glucarpidase dosing.
RESULTS: The plasma MTX concentration 48 hours after the first dose of glucarpidase decreased by at least 90% from baseline in all patients. Moreover, 87.5% of patients had plasma MTX concentrations below 1 µmol/l. Grade ≥3 adverse events were reported in 25.0% of patients, but no adverse events were found to be causally related to glucarpidase.
CONCLUSION: The results of this study are similar to those of previous clinical studies, and indicate that glucarpidase should be effective and safe in clinical practice.