Acute Lymphoblastic LeukemiaNCT04843150
Pharmacokinetics and Immunogenicity of the First Doses of PEG-Asparaginase -An ALLTogether Pilot Study
An observational study of Acute Lymphoblastic Leukemia, run by Aarhus University Hospital at 2 sites in Denmark.
Trial summary
Acute lymphoblastic leukemia (ALL) is the most common malignant disease in childhood. Survival rates exceed 90% in children and 75% in adults (aged 18-45 years). During the induction period Asparaginase is an indispensable part of the multiagent treatment, but is often associated with hypersensitivity, either with… 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
- 320 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jul 2020to 1 Oct 2023
- 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: All patients with ALL 1-45 years of age treated on the ALLTOGETHER pilot protocol in the Nordic and Baltic countries.
Who may be able to join
- Treated for acute lymphoblastic leukemia (ALL) on the ALL2GETHER pilot protocol
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Pediatrics, Skejby Hospital
Aarhus, 8200
Aarhus University Hospital, Denmark
Aarhus N, 8200
About this study
Acute lymphoblastic leukemia (ALL) is the most common malignant disease in childhood. Survival rates exceed 90% in children and 75% in adults (aged 18-45 years). During the induction period Asparaginase is an indispensable part of the multiagent treatment, but is often associated with hypersensitivity, either with clinical allergy or silent inactivation. In both cases, Asparaginase is inactivated. It is well known that truncation of Asparaginase treatment due to inactivation reduces survival. To approach understanding Asparaginase dynamics and hypersensitivity in ALL patients it is important to examine the pharmacokinetics of Asparaginase.
The aim of this study is to identify serological parameters for prediction of hypersensitivity reaction after the first doses of PEG-Asparaginase given intravenously on the ALLTogether protocol.
Read the detailed description
Asp enzyme activity is measurable in plasma, and trough levels above 100 IU/l secure effect. Patients, who have their treatment truncated, have inferior outcome. For many years prolonged Asp treatment for 30 weeks has been part of most protocols worldwide, but a recent Nordic randomized study showed that less asparaginase (8 doses vs 15 doses intramuscularly (IM)) results in the same disease-free survival and significant less toxicity in the less intensive treatment arm (6).
Accordingly, in the current Western European protocol (ALLTogether) less Asp is now given. The Nordic Countries participate in this protocol.
Unlike in the previous Nordic protocol, NOPHO ALL2008, in ALLTogether Asp will be initiated early during induction (day 4 compared to day 30) and given intravenously (IV) and not IM. In February 2017 it was approved by the NOPHO Board to do more extensive pharmacokinetic studies of IM administered PEG-asparaginase, as it has not been shown if IM or IV is preferably in respect to minimizing the incidence of hypersensitivity. Most study groups in the world use IV administration, thus NOPHO has a unique chance to illuminate inactivation after IM administration, also in adult patients. Other groups have not published this.
For >50% of the patients in ALLTogether, the induction therapy has been reduced from 4 drugs to 3 drugs. This emphasizes the importance of optimal treatment from the beginning. Therapeutic Drug Monitoring (TDM) will identify patients without activity in order to change Asp preparation. Additional sampling close after the first dose of PEG-Asp is expected to identify these patients earlier, providing an opportunity to optimize their treatment for better disease-free survival.
The aim of this study is to identify serological parameters for prediction of hypersensitivity reaction after the first dose of PEG-Asp given IV on the ALLTogether protocol.
- 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.
Number of participants with hypersensitivity Clinical allergy / silent inactivation
Patients with allergic reactions or silent inactivation
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 Jul 2020
- Primary completion30 Sep 2023
- Study completion1 Oct 2023
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
- 320 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
- Investigators
- Birgitte K Albertsen, MD, Principal investigator, M.D., PhD, Associate Professor, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843150
- Sponsor's protocol ID
- A2G-pilot-asp
- 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
- Pharmacokinetics and Immunogenicity of the First Doses of PEG-Asparaginase -An ALLTogether Pilot Study
- ClinicalTrials.gov ID
- NCT04843150
- Acronym / sponsor ID
- A2G-pilot-asp
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (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.
Acute lymphoblastic leukemia (ALL) is the most common malignant disease in childhood. Survival rates exceed 90% in children and 75% in adults (aged 18-45 years). During the induction period Asparaginase is an indispensable part of the multiagent treatment, but is often associated with hypersensitivity, either with clinical allergy or silent inactivation. In both cases, Asparaginase is inactivated. It is well known that truncation of Asparaginase treatment due to inactivation reduces survival. To approach understanding Asparaginase dynamics and hypersensitivity in ALL patients it is important to examine the pharmacokinetics of Asparaginase.
The aim of this study is to identify serological parameters for prediction of hypersensitivity reaction after the first doses of PEG-Asparaginase given intravenously on the ALLTogether protocol.
Detailed description
Asp enzyme activity is measurable in plasma, and trough levels above 100 IU/l secure effect. Patients, who have their treatment truncated, have inferior outcome. For many years prolonged Asp treatment for 30 weeks has been part of most protocols worldwide, but a recent Nordic randomized study showed that less asparaginase (8 doses vs 15 doses intramuscularly (IM)) results in the same disease-free survival and significant less toxicity in the less intensive treatment arm (6).
Accordingly, in the current Western European protocol (ALLTogether) less Asp is now given. The Nordic Countries participate in this protocol.
Unlike in the previous Nordic protocol, NOPHO ALL2008, in ALLTogether Asp will be initiated early during induction (day 4 compared to day 30) and given intravenously (IV) and not IM. In February 2017 it was approved by the NOPHO Board to do more extensive pharmacokinetic studies of IM administered PEG-asparaginase, as it has not been shown if IM or IV is preferably in respect to minimizing the incidence of hypersensitivity. Most study groups in the world use IV administration, thus NOPHO has a unique chance to illuminate inactivation after IM administration, also in adult patients. Other groups have not published this.
For >50% of the patients in ALLTogether, the induction therapy has been reduced from 4 drugs to 3 drugs. This emphasizes the importance of optimal treatment from the beginning. Therapeutic Drug Monitoring (TDM) will identify patients without activity in order to change Asp preparation. Additional sampling close after the first dose of PEG-Asp is expected to identify these patients earlier, providing an opportunity to optimize their treatment for better disease-free survival.
The aim of this study is to identify serological parameters for prediction of hypersensitivity reaction after the first dose of PEG-Asp given IV on the ALLTogether protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 1 year to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All patients with ALL 1-45 years of age treated on the ALLTOGETHER pilot protocol in the Nordic and Baltic countries.
Key inclusion criteria (1 listed)
- Treated for acute lymphoblastic leukemia (ALL) on the ALL2GETHER pilot protocol
Key exclusion criteria (1 listed)
- none
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
Number of participants with hypersensitivity Clinical allergy / silent inactivation
Time frame: 2018-2021
Patients with allergic reactions or silent inactivation
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.
Birgitte K Albertsen, MD principal investigator
M.D., PhD, Associate Professor, Aarhus University Hospital
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?
Number of participants with hypersensitivity Clinical allergy / silent inactivation (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.