LymphomaNCT05250869
Comparative Quantification of MTX and Its Metabolites Post Glucarpidase
An observational study of Lymphoma and Acute Lymphatic Leukemia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma, Acute Lymphatic Leukemia
- What is being tested?
- HPLC/MS
- How many people
- 4 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jul 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with high-dose Methotrexate and Glucarpidase
Who may be able to join
- Treatment with Glucarpidase
Who cannot join
- Lacking patient consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Quantification of MTX and Its Metabolites in Acidified vs. Non-acidified Blood Samples Post Glucarpidase Using HPLC/MS
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.
Read the detailed description
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)
- Conditions
- Lymphoma, Acute Lymphatic Leukemia
- Being tested
- HPLC/MS
- Keywords
- Preanalytical Conditions
- Medical subject headings
- Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPLC/MSDiagnostic test
Quantification of MTX and its metabolites by HPLC/MS under various preanalytical conditions
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistency of MTX concentrations in paired acidified vs. non-acidified samples
Comparison of MTX/metabolite concentrations
Measured: within 3 days of Glucarpidase treatment
Secondary outcomes (1)
Consistency of MTX concentrations in paired samples stored at -80C vs. +4C vs. ambient temperature
Comparison of MTX/metabolite concentrations
Measured: within 3 days of Glucarpidase treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start6 Jul 2022
- Primary completion31 Aug 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Schwartz, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250869
- Sponsor's protocol ID
- EA4/258/21
- Status last verified
- Jul 2024
- First submitted
- 11 Feb 2022
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Knornschild FL, Liebig S, Kiessling P, Prpic M, Kim T, Keller U, Kappert K, Schwartz S, Jahic A. Simplified preanalytical laboratory procedures for therapeutic drug monitoring (TDM) in patients treated with high-dose methotrexate (HD-MTX) and glucarpidase. Clin Chem Lab Med. 2024 Jul 15;63(1):e11-e15. doi: 10.1515/cclm-2024-0523. Print 2025 Jan 29. No abstract available.
PubMed 38997789
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Quantification of MTX and Its Metabolites in Acidified vs. Non-acidified Blood Samples Post Glucarpidase Using HPLC/MS
- ClinicalTrials.gov ID
- NCT05250869
- Acronym / sponsor ID
- EA4/258/21
- Conditions
- Lymphoma, Acute Lymphatic Leukemia
- Keywords
- Preanalytical Conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with high-dose Methotrexate and Glucarpidase
Key inclusion criteria (1 listed)
- Treatment with Glucarpidase
Key exclusion criteria (1 listed)
- Lacking patient consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPLC/MSQuantification of MTX and its metabolites by HPLC/MS under various preanalytical conditions | Diagnostic test | – |
Primary outcome
Consistency of MTX concentrations in paired acidified vs. non-acidified samples
Time frame: within 3 days of Glucarpidase treatment
Comparison of MTX/metabolite concentrations
1 secondary outcome
Consistency of MTX concentrations in paired samples stored at -80C vs. +4C vs. ambient temperature
Time frame: within 3 days of Glucarpidase treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Results publication: PubMed 38997789Knornschild FL, Liebig S, Kiessling P, Prpic M, Kim T, Keller U, Kappert K, Schwartz S, Jahic A. Simplified preanalytical laboratory procedures for therapeutic drug monitoring (TDM) in patients treated with high-dose methotrexate (HD-MTX) and glucarpidase. Clin Chem Lab Med. 2024 Jul 15;63(1):e11-e15. doi: 10.1515/cclm-2024-0523. Print 2025 Jan 29. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Acute Lymphatic Leukemia, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consistency of MTX concentrations in paired acidified vs. non-acidified samples (time frame: within 3 days of Glucarpidase treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05250869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.