Reduction of MTX Levels After Glucarpidase Treatment in DLBCL Patients at Risk of CNS (NCT05022797) | Clinical Trial Compass
TerminatedPhase 2
Reduction of MTX Levels After Glucarpidase Treatment in DLBCL Patients at Risk of CNS
Stopped: closed because of low recruitment
Spain3 participantsStarted 2021-07-19
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Subjects aged 18-70 years
✓. Patients with diagnosis of diffuse large B-cell lymphoma
✓. Patients at high risk of CNS involvement (\>2 extranodal sites plus an elevated LDH or /and involvement of high-risk extranodal sites including testes, paranasal sinuses, breast, liver, adrenal and renal)
✓. Patients who will receive HDMTX (three cycles) into R-CHOP regimen (6 cycles) prescribed according to normal clinical practice
✓. Absence of focal neurological signs
✓. Absence of CNS involvement determined by cerebrospinal fluid (CSF) cytometry flow test prior to start treatment
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
✕. Malignant disease, other than those being treated in this study. Exceptions to this exclusion include malignancies that were treated curatively and have not recurred within 2 years after completion of treatment.
What they're measuring
1
Proportion of patients who achieve significant change blood MTX levels (more than 95% reduction of blood MTX levels) at 6 hours after administration of Glucarpidase
Timeframe: 6 hours
Trial details
NCT IDNCT05022797
SponsorFundacion CRIS de Investigación para Vencer el Cáncer