Clinical trial · Interventional
Reduction of MTX Levels After Glucarpidase Treatment in DLBCL Patients at Risk of CNS
Reduction of MTX Levels After Treatment With Reduced Glucarpidase Dose in Patients With DLBCL at Risk of CNS Involvement Who Receive Cycles of HDMTX: an Open-label, Interventional, Non-randomized, Phase 2, Pilot, Multicenter Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): closed because of low recruitment
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Drug Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glucarpidase 1000 UNT [Voraxaze] | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Glucarpidase, methotrexate, R-CHOP
- description
- Glucarpidase 2000Units per dose. IV. Bolus injection over 5 minutes. Administered 12 hours following after each HDMTX cycle, for a maximum of 3 cycles.
- interventionNames
- Drug: Glucarpidase 1000 UNT [Voraxaze]
Primary outcomes (1)
- measure
- 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
- description
- As a categorical variable: \>95% reduction of MTX (yes/no) after 6 hours after administration of 2,000 units of Glucarpidase.
Secondary outcomes (3)
- measure
- Change blood MTX levels achieved at 15 minutes, 6 hours, 12 hours and 24 hours after administration of Glucarpidase
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects aged 18-70 years 2. Patients with diagnosis of diffuse large B-cell lymphoma 3. 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) 4. Patients who will receive HDMTX (three cycles) into R-CHOP regimen (6 cycles) prescribed according to normal clinical practice 5. Absence of focal neurological signs 6. Absence of CNS involvement determined by cerebrospinal fluid (CSF) cytometry flow test prior to start treatment 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 8. Absolute neutrophil count 1800-7500/µL, platelet count 130.000- 450.000/ µL, hemoglobin 13,5-18 g/dL, 9. Serum creatinine ≤1.5 x the upper limit of normal (ULN) or glomerular filtration rate (GFR) ≥60ml/min/1.73m\^2 10. Total serum bilirubin ≤2 x ULN. Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤2.5 x ULN 11. Ability to understand and the willingness to sign a written informed consent document 12. In women of childbearing potential (from menarche and until becoming post-menopausal \[i.e., no menses for 12 months with an alternative medical cause\], unless permanently sterile) and men, use of highly effective measure of contraception (abstinence, hormonal contraception, intra-uterine device \[IUD\], intrauterine hormone-releasing system, \[IUS\], or anatomical sterility in self or partner) committed during 3 months after the last IMP administration. Exclusion Criteria: 1. 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. 2. Patients suffered from cardiovascular diseases (arrhythmias, previous heart failure, thromboembolic disease) 3. Previous treatment with Glucarpidase 4. Pregnant or breastfeeding women 5. Concomitant treatment with agents which interact with methotrexate metabolism or excretion 6. Known intolerance/hypersensitivity to Glucarpidase or any of its excipients.
References
Publications (0)
Data not yet available