Acute Lymphoblastic LeukemiaNCT04843514
TDM of Asparaginase in ALL2008
An observational study of Acute Lymphoblastic Leukemia, run by Aarhus University Hospital at 2 sites in Denmark.
Trial summary
Asparaginase is a cornerstone in the treatment of ALL. In most contemporary protocols like in NOPHO ALL2008 prolonged asparaginase treatment has been implemented. Publish data from NOPHO ALL2008 show sufficient treatment of the majority of patients (analysing trough levels of asparaginase after 2 weeks) but 13% of the… Read more about this study
- Who is it for?
- Ages 1 year to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- How many people
- 765 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Apr 2021to 31 Jan 2024
- 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 1 year to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Alle patients in the NOPHO countries aged 1-45 years treated for ALL on the NOPHO ALL2008 protocol and have asparaginase-activity-samples sent to Aarhus.
Who may be able to join
- ALL treated on the NOPHO ALL2008 protocol, age 1-45 years.
Who cannot join
- No samples sent
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital, Denmark
Aarhus N, 8200
Aarhus University Hospital
Aarhus N, 8200
About this study
Official title: Therapeutic Drug Monitoring of Asparaginase in Patients Treated on the NOPHO ALL2008 Protocol
Asparaginase is a cornerstone in the treatment of ALL. In most contemporary protocols like in NOPHO ALL2008 prolonged asparaginase treatment has been implemented.
Publish data from NOPHO ALL2008 show sufficient treatment of the majority of patients (analysing trough levels of asparaginase after 2 weeks) but 13% of the patients experience an allergic reaction to this foreign protein (85% of them after the 2nd or 3rd dose) and they have no enzyme activity even before the reaction, meaning that they don't benefit from the treatment at all. In addition 4-5% of the patients have no enzyme activity through the whole treatment without hypersensitivity symptoms. So in reality approximately 20% of the patients don't receive any asparaginase treatment. Therapeutic Drug Monitoring (TDM) of asparaginase has been established in Aarhus, Denmark, under the leadership of Birgitte Klug Albertsen (BKA). From February 2017 the centers have been invited to send samples (extended sampling) in order to gain more knowledge about the pharmacokinetics, to identify patients without activity and to establish the logistics for TDM of asparaginase, which will be mandatory in the next protocol ALLTogether, presumably opening in 2018.
Read more
From February 2016 an extended sampling for enzyme activity measurements was started and will continue until NOPHO ALL2008 closes. These samples will make it possible to do more in depth pharmacokinetic studies as well as identify the optimal sampling time points for identifying no-activity patients in the future.
A database is being developed for TDM in ALLTogether, but it will also include all the asparaginase measurements in ALL2008.
- Conditions
- Acute Lymphoblastic Leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the pharmacokinetics after administration of PEG-asparaginase 1000 IU/m2 in NOPHO ALL2008, cohort February 2017 and on
Measured: 2018-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 Apr 2021
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- 765 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgitte Klug Albertsen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843514
- Sponsor's protocol ID
- NOPHO-ALL2008-phamacokinetics
- Status last verified
- Feb 2024
- First submitted
- 9 Apr 2021
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Monitoring of Asparaginase in Patients Treated on the NOPHO ALL2008 Protocol
- ClinicalTrials.gov ID
- NCT04843514
- Acronym / sponsor ID
- NOPHO-ALL2008-phamacokinetics
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 765 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 13 Apr 2021 (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.
Asparaginase is a cornerstone in the treatment of ALL. In most contemporary protocols like in NOPHO ALL2008 prolonged asparaginase treatment has been implemented.
Publish data from NOPHO ALL2008 show sufficient treatment of the majority of patients (analysing trough levels of asparaginase after 2 weeks) but 13% of the patients experience an allergic reaction to this foreign protein (85% of them after the 2nd or 3rd dose) and they have no enzyme activity even before the reaction, meaning that they don't benefit from the treatment at all. In addition 4-5% of the patients have no enzyme activity through the whole treatment without hypersensitivity symptoms. So in reality approximately 20% of the patients don't receive any asparaginase treatment. Therapeutic Drug Monitoring (TDM) of asparaginase has been established in Aarhus, Denmark, under the leadership of Birgitte Klug Albertsen (BKA). From February 2017 the centers have been invited to send samples (extended sampling) in order to gain more knowledge about the pharmacokinetics, to identify patients without activity and to establish the logistics for TDM of asparaginase, which will be mandatory in the next protocol ALLTogether, presumably opening in 2018.
From February 2016 an extended sampling for enzyme activity measurements was started and will continue until NOPHO ALL2008 closes. These samples will make it possible to do more in depth pharmacokinetic studies as well as identify the optimal sampling time points for identifying no-activity patients in the future.
A database is being developed for TDM in ALLTogether, but it will also include all the asparaginase measurements in ALL2008.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Alle patients in the NOPHO countries aged 1-45 years treated for ALL on the NOPHO ALL2008 protocol and have asparaginase-activity-samples sent to Aarhus.
Key inclusion criteria (1 listed)
- ALL treated on the NOPHO ALL2008 protocol, age 1-45 years.
Key exclusion criteria (1 listed)
- No samples sent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of the pharmacokinetics after administration of PEG-asparaginase 1000 IU/m2 in NOPHO ALL2008, cohort February 2017 and on
Time frame: 2018-2021
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 6 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, run by Aarhus University Hospital at 2 sites in Denmark.
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 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Description of the pharmacokinetics after administration of PEG-asparaginase 1000 IU/m2 in NOPHO ALL2008, cohort February 2017 and on (time frame: 2018-2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2024.