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Reduction of MTX Levels After Glucarpidase Treatment in DLBCL Patients at Risk of CNS

NCT05022797 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-05-13

No results posted yet for this study

Summary

Diffuse large B-cell lymphoma (DLBCL) is an aggressive subset of non-Hodgkin's lymphoma (NHL). Central nervous system (CNS) involvement in patients with NHL is a serious complication. The outcome of patients with CNS relapse is extremely poor, with a median survival of 4-6 months.

One approach to reduce CNS relapse in high-risk patients is the use of systemic high-dose intravenous (iv) methotrexate (HMTX) chemotherapy. Currently available methods of MTX clearance, including dialysis-based methods, have shown limited efficacy.

Glucarpidase hydrolyses MTX to inactive metabolites that are partially metabolised by the liver, thus providing an alternative route of limiting renal excretion.

The administration of Glucarpidase could prevent MTX toxicity as a whole as well as the following consequences. The aim of this study is to analyse the prophylactic effect of 2,000 units of glucarpidase administered after 12 hours of HDMTX on MTX clearance and on the incidence and severity of MTX-related toxicity.

Conditions

  • Diffuse Large B-Cell Lymphoma
  • Drug Toxicity

Interventions

DRUG

Glucarpidase 1000 UNT [Voraxaze]

2 vials of 1000 units per vial

Sponsors & Collaborators

  • BioClever 2005 S.L.

    collaborator OTHER

  • Eurofins ADME, S.L.

    collaborator UNKNOWN

  • NTShub, S.L.

    collaborator UNKNOWN

  • BTG International Inc.

    collaborator OTHER

  • Fundacion CRIS de Investigación para Vencer el Cáncer

    lead OTHER

Principal Investigators

  • Adolfo De la Fuente, PD · MD Anderson

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-19
Primary Completion
2022-11-22
Completion
2022-11-22

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05022797 on ClinicalTrials.gov