An observational study in Lymphoma and Acute Lymphatic Leukemia, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2024-07-22.
Sponsored by Charite University, Berlin, Germany · Observational
Acidification (i.e., addition of hydrochloric acid) of plasma samples from patients who have received Glucarpidase post high-dose MTX treatment is regarded as a necessary preanalytic step to avoid further in vitro enzymatic cleavage of MTX. However, it is unclear whether this acidification step is essential. A comparative study, which evaluates concentrations of MTX and its metabolites in paired (acidified versus non-acidified) plasma samples, has not yet been performed. Processing plasma samples without acidification would facilitate quantification of MTX, including plasma samples from patients treated at centers without adequate laboratory facilities.
Stored plasma samples (paired - acidified and non-acidified) from the specimens collection ('Tumorbiobank') of the Charité Comprehensive Cancer Center will be analysed by HPLC/MS.
A total of 136 samples from patients post Voraxaze across 3 levels of MTX concentrations:
30 without additive, 10 with 0.9% NaCl, 30 with HCl (stored at -80C) 9 without additive, 9 with HCl (stored at +4C and analysed after 3-5 days) 9 without additive, 9 with HCl (stored at -20C and analysed after 3-5 days) 30 with HCl (stored at +4C versus ambient temperature)
1,780 studies on the registry are indexed under Leukemia, Lymphoid; 176 are open to participants now.
This study's enrollment of 4 is below the median of 112 across 227 observational studies indexed under Leukemia, Lymphoid.
Browse Leukemia, Lymphoid studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated with high-dose Methotrexate and Glucarpidase
Exclusion Criteria:
Quantification of MTX and its metabolites by HPLC/MS under various preanalytical conditions
Consistency of MTX concentrations in paired acidified vs. non-acidified samples
Comparison of MTX/metabolite concentrations
Time frame: within 3 days of Glucarpidase treatment
Consistency of MTX concentrations in paired samples stored at -80C vs. +4C vs. ambient temperature
Comparison of MTX/metabolite concentrations
Time frame: within 3 days of Glucarpidase treatment
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany