HM-178: Assessing Methods for Improvement in Methotrexate Toxicity Management and Detection of Central Nervous System Involvement of Aggressive Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Lymphoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 65 years and 125 years
- Gender
- Both males and females
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 s...
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.
Tracking Information
- NCT #
- NCT04668768
- Collaborators
- Not Provided
- Investigators
- Not Provided
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