Acute Lymphoblastic LeukemiaNCT04187248
The Association Between Asparaginase Enzyme Activity Levels and Toxicities in Childhood Acute Lymphoblastic Leukaemia in NOPHOALL 2008
An observational study of Acute Lymphoblastic Leukemia, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Evaluation of the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with Acute Lymphoblastic Leukemia treated in the NOPHO-ALL 2008 protocol. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Asparaginase
- How many people
- 1,248 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2008to 1 Mar 2017
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with ALL, aged 1-17.9 years at time of diagnosis
Who may be able to join
- ALL, standard or intermediate risk
- Included in the NOPHO ALL2008 protocol (July 2016 - February 2016)
- Children (1-17,9 years at diagnosis)
Who cannot join
- ALL: high risk disease, ph-, genetic predisposition, bilinear ALL
- < 2 samples for asparaginase enzyme activity measurements
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Department of Pediatrics Skejby Hospital
Aarhus, Aarhus N, 8200
About this study
Evaluation of the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with Acute Lymphoblastic Leukemia treated in the NOPHO-ALL 2008 protocol.
Read the detailed description
Asparaginase treatment in acute lymphoblastic leukemia in children is jeopardized by a huge toxicity burden and the toxicities are often preventing further treatment. The most common asparaginase associated toxicities are hypersensitivity, pancreatitis, thromboembolism and osteonecrosis.
In the NOPHO ALL2008 protocol asparaginase associated toxicities have been registered since the protocol opened in July 2008. In addition asparaginase enzyme activity measurements have been done before every asparaginase administration and analyzed retrospectively.
This study evaluate the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with ALL treated in the NOPHO-ALL 2008 protocol.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Asparaginase
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsparaginaseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with hypersensitivity
Clinical allergy / silent inactivation.
Measured: July 2008 - February 2016
Number of participants with asparaginase associated pancreatitis
Measured: July 2008 - February 2016
Number of participants with tromboembolism
Measured: July 2008 - February 2016
Number of participants with osteonecrosis
Measured: July 2008 - February 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Jul 2008
- Primary completion28 Feb 2016
- Study completion1 Mar 2017
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
- Other
- Enrolment
- 1,248 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
- NCT04187248
- Sponsor's protocol ID
- NOPHOALL2008_asp-tox
- Status last verified
- Aug 2023
- First submitted
- 3 Dec 2019
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Asparaginase Enzyme Activity Levels and Toxicities in Childhood Acute Lymphoblastic Leukaemia in NOPHOALL 2008
- ClinicalTrials.gov ID
- NCT04187248
- Acronym / sponsor ID
- NOPHOALL2008_asp-tox
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,248 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2008 (actual)
- Primary completion
- 28 Feb 2016 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 5 Dec 2019 (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.
Evaluation of the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with Acute Lymphoblastic Leukemia treated in the NOPHO-ALL 2008 protocol.
Detailed description
Asparaginase treatment in acute lymphoblastic leukemia in children is jeopardized by a huge toxicity burden and the toxicities are often preventing further treatment. The most common asparaginase associated toxicities are hypersensitivity, pancreatitis, thromboembolism and osteonecrosis.
In the NOPHO ALL2008 protocol asparaginase associated toxicities have been registered since the protocol opened in July 2008. In addition asparaginase enzyme activity measurements have been done before every asparaginase administration and analyzed retrospectively.
This study evaluate the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with ALL treated in the NOPHO-ALL 2008 protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with ALL, aged 1-17.9 years at time of diagnosis
Key inclusion criteria (3 listed)
- ALL, standard or intermediate risk
- Included in the NOPHO ALL2008 protocol (July 2016 - February 2016)
- Children (1-17,9 years at diagnosis)
Key exclusion criteria (2 listed)
- ALL: high risk disease, ph-, genetic predisposition, bilinear ALL
- < 2 samples for asparaginase enzyme activity measurements
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 |
|---|---|---|
| Asparaginase | Drug | – |
Primary outcome
Number of participants with hypersensitivity
Time frame: July 2008 - February 2016
Clinical allergy / silent inactivation.
Number of participants with asparaginase associated pancreatitis
Time frame: July 2008 - February 2016
Number of participants with tromboembolism
Time frame: July 2008 - February 2016
Number of participants with osteonecrosis
Time frame: July 2008 - February 2016
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 25 Aug 2023.
- Individual participant dataSharing planned: No
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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 Acute Lymphoblastic Leukemia, run by Aarhus University Hospital at 1 site 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 3 inclusion and 2 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 25 Aug 2023. 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 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?
Number of participants with hypersensitivity (time frame: July 2008 - February 2016). The study lists 4 primary outcomes in all. 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 25 Aug 2023.