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Clinical Trial Summary

This is a study to use glucarpidase prophylactically to treat methotrexate induced toxicities in lymphoma patients with cerebral involvement.


Clinical Trial Description

Treatment and prophylaxis against CNS (central nervous system) lymphoma typically consist of a regimen containing high dose methotrexate (HD MTX), which requires inpatient monitoring in order to ensure adequate clearance of methotrexate levels (MTX). The goal of this prospective, multi-institution study is to evaluate the effect of prophylactic glucarpidase in patients receiving high dose MTX and are at increased risk of delayed MTX clearance and nephrotoxicity. Glucarpidase is a recombinant bacterial enzyme (carboxypeptidase G2) that can convert MTX to non-cytotoxic metabolites (DAMPA). This is the first controlled trial comparing glucarpidase with supportive care alone in patients with MTX induced nephrotoxicity and delayed MTX clearance. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04668768
Study type Interventional
Source Fox Chase Cancer Center
Contact
Status Suspended
Phase Phase 2
Start date April 16, 2021
Completion date April 2025

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