Relapse LeukemiaNCT03987542
Outcome Following Truncation of Asparaginase
An observational study of Relapse Leukemia, run by Birgitte Klug Albertsen at 1 site in Denmark.
Trial summary
This study aimed to investigate the outcome of patients who had their asparaginase treatment truncated in the NOPHO ALL2008 protocol. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Relapse Leukemia
- How many people
- 1,401 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2008to Jun 2020
- How long will I take part?
- 3 Years
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged 1-17.9 years at time of diagnosis.
Who may be able to join
- Children treated according to the NOPHO ALL2008 protocol from the 1st of July 2008 - 28th of February 2016.
Who cannot join
- Bilineage ALL
- Pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week
- ALL predisposition syndromes
- Previous cancer
- Off protocol administration of additional chemotherapy during induction therapy
- Sexually active females not using contraception
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
Official title: Outcome Following Truncation of Asparaginase in the NOPHO ALL2008 Protocol
This study aimed to investigate the outcome of patients who had their asparaginase treatment truncated in the NOPHO ALL2008 protocol.
Read the detailed description
Overall survival for children with ALL is now above 90% in several protocols, but asparaginase associated toxicities still constitutes a significant problem as they, besides causing acute morbidity and mortality, can cause truncation of treatment with a subsequent increased risk of relapse.
The most frequent toxicities causing asparaginase truncations are hypersensitivity, pancreatitis and thrombosis. Especially hypersensitivity constitutes a problem due to silencing antibodies, not only in patients with clinical hypersensitivity but also in patients without clinical symptoms (silent inactivation).
In the NOPHO ALL2008 protocol asparaginase associated toxicities and truncation of asparaginase have been registered since the protocol opened in 2008. In addition asparaginase enzyme activity measurements have been done before every asparaginase administration and analyzed retrospectively.
The primary aim of this study was to investigate if patients with truncation of asparaginase or lack of asparaginase enzyme activity had a different risk of relapse compared to patients who received full asparaginase treatment. Secondary we aimed to explore if patients who received less than 50% of their planned asparaginase dosages had a different risk of relapse compared to those who received 50% or more.
- Conditions
- Relapse Leukemia
- Keywords
- Acute lymphoblastic leukemia, Asparaginase, Truncation, Toxicitities
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Patients who had their asparaginase treatment truncated or had no asparaginase enzyme activity. | |
| Unexposed | Patients who did not have their asparaginase treatment truncated and had measurable asparaginase enzyme activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of relapse
Do patients with truncation of asparaginase treatment or no enzyme activity (truncated) have a different risk of relapse compared to patients who have not been truncated and who have measurable enzyme activity (non-truncated)
Measured: 5 years
Secondary outcomes (1)
50% of asparagine doses
Do patients who receive less than 50% of their planned asparaginase dosages have a different risk of relapse compared to those who receive 50% or more.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study startJul 2008
- Primary completionJun 2020
- Study completionJun 2020
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 Relapse LeukemiaStudies of the same condition, open and under way.
- 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
- 1,401 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Birgitte Klug Albertsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Birgitte Klug Albertsen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987542
- Sponsor's protocol ID
- Asparaginase_truncation_NOPHO
- Status last verified
- May 2022
- First submitted
- 12 Jun 2019
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gottschalk Hojfeldt S, Grell K, Abrahamsson J, Lund B, Vettenranta K, Jonsson OG, Frandsen TL, Wolthers BO, Marquart HV, Vaitkeviciene G, Lepik K, Heyman M, Schmiegelow K, Albertsen BK. Relapse risk following truncation of pegylated asparaginase in childhood acute lymphoblastic leukemia. Blood. 2021 Apr 29;137(17):2373-2382. doi: 10.1182/blood.2020006583.
PubMed 33150360
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Following Truncation of Asparaginase in the NOPHO ALL2008 Protocol
- ClinicalTrials.gov ID
- NCT03987542
- Acronym / sponsor ID
- Asparaginase_truncation_NOPHO
- Conditions
- Relapse Leukemia
- Keywords
- Acute lymphoblastic leukemia, Asparaginase, Truncation, Toxicitities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,401 participants (actual)
- Lead sponsor
- Birgitte Klug AlbertsenUniversity, hospital or other
- Study start
- Jul 2008 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 17 Jun 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.
This study aimed to investigate the outcome of patients who had their asparaginase treatment truncated in the NOPHO ALL2008 protocol.
Detailed description
Overall survival for children with ALL is now above 90% in several protocols, but asparaginase associated toxicities still constitutes a significant problem as they, besides causing acute morbidity and mortality, can cause truncation of treatment with a subsequent increased risk of relapse.
The most frequent toxicities causing asparaginase truncations are hypersensitivity, pancreatitis and thrombosis. Especially hypersensitivity constitutes a problem due to silencing antibodies, not only in patients with clinical hypersensitivity but also in patients without clinical symptoms (silent inactivation).
In the NOPHO ALL2008 protocol asparaginase associated toxicities and truncation of asparaginase have been registered since the protocol opened in 2008. In addition asparaginase enzyme activity measurements have been done before every asparaginase administration and analyzed retrospectively.
The primary aim of this study was to investigate if patients with truncation of asparaginase or lack of asparaginase enzyme activity had a different risk of relapse compared to patients who received full asparaginase treatment. Secondary we aimed to explore if patients who received less than 50% of their planned asparaginase dosages had a different risk of relapse compared to those who received 50% or more.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | –Patients who had their asparaginase treatment truncated or had no asparaginase enzyme activity. |
| Unexposed | – | –Patients who did not have their asparaginase treatment truncated and had measurable asparaginase enzyme activity |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged 1-17.9 years at time of diagnosis.
Key inclusion criteria (1 listed)
- Children treated according to the NOPHO ALL2008 protocol from the 1st of July 2008 - 28th of February 2016.
Key exclusion criteria (6 listed)
- Bilineage ALL
- Pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week
- ALL predisposition syndromes
- Previous cancer
- Off protocol administration of additional chemotherapy during induction therapy
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
Risk of relapse
Time frame: 5 years
Do patients with truncation of asparaginase treatment or no enzyme activity (truncated) have a different risk of relapse compared to patients who have not been truncated and who have measurable enzyme activity (non-truncated)
1 secondary outcome
50% of asparagine doses
Time frame: 5 years
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 20 May 2022.
- Derived from this study: PubMed 33150360Gottschalk Hojfeldt S, Grell K, Abrahamsson J, Lund B, Vettenranta K, Jonsson OG, Frandsen TL, Wolthers BO, Marquart HV, Vaitkeviciene G, Lepik K, Heyman M, Schmiegelow K, Albertsen BK. Relapse risk following truncation of pegylated asparaginase in childhood acute lymphoblastic leukemia. Blood. 2021 Apr 29;137(17):2373-2382. doi: 10.1182/blood.2020006583.
- 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 Relapse Leukemia, run by Birgitte Klug Albertsen 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 1 inclusion and 6 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 20 May 2022. 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?
Risk of relapse (time frame: 5 years). 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 NCT03987542, 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 20 May 2022.