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Methotrexate Early Toxicity Monitoring in Primary Central Nervous System Lymphomas (PCNSL)
High-dose methotrexate (MTX) is the main componement of first line treatment in primary central nervous system lymphoma. Renal toxicity is the main dose limiting toxicity because of major MTX elimination by the kidneys. MTX crystallizes in renal tubules, leading to a renal failure (RF) and further delaying its elimination. When RF occurs, MTX accumulates, prolonging the duration of treatment exposure. MTX prolonging exposure can cause life-threatening complications and delay further treatments in the patient. Preventive measures have been developped, such as alkaline fluid hyperhydration and folic acid administration, to try to reduce the risk of these adverse events. In suspected severe RF in link to MTX is suspected, glucarpidase can be administared. However, this is an expensive treatment and not all patients recover normal renal function despite its use. MTX is an essential treatment for the management of PCNSL which is currently a curable disease especially in patients who are able to receive a consolidation treatment as thiotepa-based intensive consolidation followed by autologous stem cell transplantation (IC-ASCT). IC-ASCT requires a normal renal function, which could be impaired by severe RF secondary to MTX. The purpose of the study is to investigate how early dosing MTX could be used to simulate late concentrations. Early monitoring of MTX elimination could be implemented to identify patients at risk of delayed elimination and thus introduce rapid mesures as early administration of glucarpidase.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Assistance Publique - Hôpitaux de Marseille
Marseille, France
Start Date
April 1, 2026
Primary Completion Date
April 1, 2027
Completion Date
December 1, 2027
Last Updated
February 12, 2026
50
ESTIMATED participants
methotrexate plasmatic dosing
OTHER
Lead Sponsor
Assistance Publique Hopitaux De Marseille
NCT02203526
NCT06175000
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT03328078