No registrations found.
ID
Source
Brief title
Health condition
leukaemia and central nervous system lymphoma
acute leukemie en centraal zenuwstelsel lymfoom
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Secondary outcome
To investigate whether intracellular MTX levels are related to toxicity in adult HD-MTX therapy
Background summary
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.
Study objective
intracellular MTX levels predict toxicity in HD-MTX therapy
Study design
Pre MTX
72 hours post MTX
Intervention
bloodsampling
S. Heil
Postbus 2040
Rotterdam 3000 CA
The Netherlands
email: s.heil@erasmusmc.nl
S. Heil
Postbus 2040
Rotterdam 3000 CA
The Netherlands
email: s.heil@erasmusmc.nl
Inclusion criteria
- All adult patients treated in the Erasmus MC with HD-MTX for a CNS lymphoma or ALL
- Written informed consent
Exclusion criteria
none
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5465 |
| NTR-old | NTR5609 |
| Other | NL54566.078.15 : MEC 2015-659 |