NCT04668768

HM-178: Assessing Methods for Improvement in Methotrexate Toxicity Management and Detection of Central Nervous System Involvement of Aggressive Lymphoma

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	Glucarpidase	Glucarpidase injection to prevent toxicities due to high dose methotrexate treatment

Timeline

• Start date: 2021-04-16
• Primary completion: 2024-12-01
• Completion: 2025-04-01
• First posted: 2020-12-16
• Last updated: 2024-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study