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Not yet recruiting NCT07406230

Methotrexate Early Toxicity Monitoring

No phase Interventional Primary Central Nervous System Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: methotrexate plasmatic dosing.
Who it may be relevant to
Registry conditions: Primary Central Nervous System Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Methotrexate Early Toxicity Monitoring in Primary Central Nervous System Lymphomas (PCNSL)

Overview

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.

Interventions

  • Other methotrexate plasmatic dosing
    Methotrexate (MTX) dosage at 2,4,6,8,24 and 48 hours

Primary outcome measures

  • Accuracy measurement of Bayesian model [Time frame: 48 hours post MTX]
Secondary outcome measures (4)
  • Determine the Bayesian model for predicting renal toxicity of MTX T48H using a pharmacometric approach (in silico modeling) based on early dosing of methotrexate in plasma [Time frame: 48 hours post MTX]
  • Determine the bayesian model for predicting MTX clearance 72 hours after MTX using a pharmacometric approach (in silico modeling) based on early dosing of methotrexate in plasma [Time frame: 72 hours post MTX]
  • Estimate in an exploratory approach the performance of the Bayesian model for predicting the delay in MTX elimination at 48 hours using a pharmacometric approach (in silico modeling) [Time frame: 48 hours post]
  • Estimate in an exploratory approach the performance of the Bayesian model for predicting overexposure to MTX at 48 hours using a pharmacometric approach (in silico modeling) [Time frame: 48 hours post MTX]

Eligibility criteria

Inclusion criteria

  • Adult patient aged 18 years or older,
  • Patient with a primary lymphoma of the central nervous system, histologically or cytologically proven,
  • Patient eligible for high-dose methotrexate treatment (> at 500 mg/m 2), in the first line of treatment,
  • Patient who has received information regarding the study and signed an informed consent,
  • Patient beneficiary or entitled to a social security scheme.

Exclusion criteria

  • Patient treated with a therapy complementary to the standard 1st-line treatment based on high-dose MTX as part of a clinical research protocol,
  • Patient in a period of exclusion from another research protocol at the time of signing consent,
  • Subjects covered by articles L1121-5 to 1121-8 of the Public Health Code (minor patient, adult patient under guardianship or curatorship, patient deprived of liberty, pregnant or breastfeeding woman).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Assistance Publique - Hôpitaux de Marseille — Marseille

Identifiers

NCT: NCT07406230 · RCAPHM24_0313 · ID RCB: 2025-A01802-47

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗