intracellular MTX levels predict toxicity in HD-MTX therapy
ID
Bron
Verkorte titel
Aandoening
leukaemia and central nervous system lymphoma
acute leukemie en centraal zenuwstelsel lymfoom
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To 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
Achtergrond van het onderzoek
High-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.
Doel van het onderzoek
intracellular MTX levels predict toxicity in HD-MTX therapy
Onderzoeksopzet
Pre MTX
72 hours post MTX
Onderzoeksproduct en/of interventie
bloodsampling
Publiek
S. Heil
Postbus 2040
Rotterdam 3000 CA
The Netherlands
email: s.heil@erasmusmc.nl
Wetenschappelijk
S. Heil
Postbus 2040
Rotterdam 3000 CA
The Netherlands
email: s.heil@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- All adult patients treated in the Erasmus MC with HD-MTX for a CNS lymphoma or ALL
- Written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
none
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL5465 |
NTR-old | NTR5609 |
Ander register | NL54566.078.15 : MEC 2015-659 |