Reduction of MTX Levels After Glucarpidase Treatment in DLBCL Patients at Risk of CNS
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Fundacion CRIS de Investigación para Vencer el Cáncer
Collaborators:
BioClever 2005 S.L. BTG International Inc. Eurofins ADME, S.L. NTShub, S.L.