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van CCT (UK)


Intracellular drug measurements to predict toxicity in high-dose methotrexate therapy in leukaemia and central nervous system lymphoma.


- candidate number23546
- NTR NumberNTR5609
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-dec-2015
- Secondary IDsMEC 2015-659 NL54566.078.15
- Public TitleIntracellular drug measurements to predict toxicity in high-dose methotrexate therapy in leukaemia and central nervous system lymphoma.
- Scientific TitleIntracellular drug measurements to predict toxicity in high-dose methotrexate therapy in leukaemia and central nervous system lymphoma: a pilot study
- ACRONYMHAL study
- hypothesisintracellular MTX levels predict toxicity in HD-MTX therapy
- Healt Condition(s) or Problem(s) studiedAcute Lymfatic Leukemia (ALL), Lymphoma
- Inclusion criteria- All adult patients treated in the Erasmus MC with HD-MTX for a CNS lymphoma or ALL
- Written informed consent
- Exclusion criterianone
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2016
- planned closingdate1-sep-2018
- Target number of participants60
- Interventionsbloodsampling
- Primary outcomeTo investigate the pharmacokinetics and determinants of MTX-PG accumulation in plasma, lymphocytes and erythrocytes in adult CNS lymphoma and leukemia patients treated with HD-MTX
- Secondary outcomeTo investigate whether intracellular MTX levels are related to toxicity in adult HD-MTX therapy
- TimepointsPre MTX 72 hours post MTX
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. S. Heil
- CONTACT for SCIENTIFIC QUERIESDr. S. Heil
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- Publications
- Brief summaryHigh-dose Methotrexate (HD-MTX) chemotherapy is the cornerstone of the treatment of central nervous system lymphoma (PCNSL) and acute lymphoblastic leukaemia (ALL) . Although MTX is a relatively safe and effective drug, >35% of patients experience adverse events, which is poorly predicted by the highly variable plasma MTX levels. Intracellular MTX levels have been shown to correlate better with clinical outcome in ALL but are difficult to measure. Recently, we developed an intracellular MTX assay that can be used in routine clinical practice. We hypothesize that intracellular MTX levels predict toxicity in HD-MTX therapy. The aim of this study is to investigate A) cellular MTX pharmacokinetics and its determinants, and B) whether intracellular MTX levels are related to toxicity in adult HD-MTX administration.
- Main changes (audit trail)
- RECORD29-dec-2015 - 14-feb-2016


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