Clinical trial · Observational
Coproporphyrine Isomers and Methotrexate Elimination
Urinary Ratio of the Coproporphyrins Isomers I and III and Its Relationships With Methotrexate Elimination in Patients With a Lymphoid Malignancy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
High dose methotrexate (MTX) is responsible of severe toxicity in patients in whom elimination from plasma is delayed. Factors responsible for MTX accumulation are partly known but some patients still experience toxicity despite adequate measures being taken. Our hypothesis is that renal tubular secretion may be impaired in these patients. This study aims at evaluating the performance of the UCP ratio (urinary ratio of coproporphyrins), a putative biomarker of tubular secretion, in predicting delayed MTX elimination.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Burkitt Lymphoma | Burkitt Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Central Nervous System Neoplasms | Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Precursor B-Cell Lymphoblastic Leukemia-Lymphoma | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 1
Primary outcomes (1)
- measure
- MTX concentrations
- timeFrame
- at the end of MTX infusion and every 24-hours until concentrations reach 0,2µM.
Secondary outcomes (4)
- measure
- The UCP I/(I+III) ratio
- timeFrame
- before and at the end of MTX infusion and at the end of hospitalisation.
- measure
- Five polymorphisms of the ABCC2 gene (-24C/T, 1249G/A, 3563T/A, 4544G/A)
- timeFrame
- during the study
- measure
- Blood cells count .
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria : * Patients receiving HDMTX (≥1g/m2) for a primitive cerebral lymphoma, a large cell lymphoma, a lymphoblastic lymphoma, a Burkitt's lymphoma or an acute lymphoblastic leukaemia, * over 18 years old, * Signed informed consent. * Affiliated to a medical assurance. * Able to respect the protocol. * Effective contraception for women. Exclusion criteria : * renal failure, * liver failure, * hepatic cytolysis, * chronic respiratory deficiency, * pregnancy, * breast-feeding, * Concomitant medication: phenytoin, probenecid, trimethoprim, phenylbutazone, salicylates, non steroid anti-inflammatory, yellow fever vaccine. * Patient included in another study in the four weeks preceding his inclusion.
References
Publications (1)
- DERIVEDBenz-de Bretagne I, Zahr N, Le Gouge A, Hulot JS, Houillier C, Hoang-Xuan K, Gyan E, Lissandre S, Choquet S, Le Guellec C. Urinary coproporphyrin I/(I + III) ratio as a surrogate for MRP2 or other transporter activities involved in methotrexate clearance. Br J Clin Pharmacol. 2014 Aug;78(2):329-42. doi: 10.1111/bcp.12326. PMID 24433481