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[Phase II study of glucarpidase in Japanese patients with delayed methotrexate clearance after high-dose methotrexate
Keiko Okada1, Chitose Ogawa2, Rishu Kayatani1
1Department of Pediatrics Hematology/Oncology, Osaka City General Hospital.
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.
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