Lymphoma, Large B-Cell, Diffuse Clinical Trial
— COMETHOfficial title:
Urinary Ratio of the Coproporphyrins Isomers I and III and Its Relationships With Methotrexate Elimination in Patients With a Lymphoid Malignancy
Verified date | January 2009 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Observational |
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.
Status | Completed |
Enrollment | 85 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
France | Pitié-Salpêtrière Hospital | Paris | |
France | University Hospital Centre of Tours | Tours |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MTX concentrations | at the end of MTX infusion and every 24-hours until concentrations reach 0,2µM. | Yes | |
Secondary | The UCP I/(I+III) ratio | before and at the end of MTX infusion and at the end of hospitalisation. | Yes | |
Secondary | Five polymorphisms of the ABCC2 gene (-24C/T, 1249G/A, 3563T/A, 4544G/A) | during the study | Yes | |
Secondary | Blood cells count . | before MTX infusion and at the end of hospitalisation | Yes | |
Secondary | Renal function | before MTX infusion and at the end of hospitalisation | Yes |
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