Phase 2 study of glucarpidase in patients with delayed methotrexate elimination after high-dose methotrexate therapy.

ABSTRACT:

Purpose

High-dose methotrexate therapy (HD-MTX) is a standard treatment for various malignant tumors, but approximately 1-10% of patients experience delayed MTX elimination (DME) that can induce organ damage. Glucarpidase can hydrolyze MTX and thereby lower the level of active MTX in the blood. A multicenter, open-label, phase II investigator-initiated trial (CPG2-PII study) was conducted to evaluate glucarpidase rescue therapy in Japanese patients who showed DME after HD-MTX treatment. To confirm the robustness of this therapy, further corporate-sponsored clinical trial (OP-07-001 study) was conducted.

Methods

The primary endpoint in the CPG2-PII study was to evaluate the proportion of patients of the percentage clinical important reduction (CIR) as an indicator of MTX conc

SUBMITTER: Ogawa A 

PROVIDER: S-EPMC11258064 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature