Acute Lymphoblastic LeukemiaPhase 4NCT00192673
Poly(Ethylene Glycol)(PEG)-Asparaginase During Two Treatment Courses
A Phase 4 study testing PEG-asparaginase in people with Acute Lymphoblastic Leukemia, run by Nordic Society for Pediatric Hematology and Oncology at 1 site in Denmark.
Trial summary
The purpose of this study is 1. to determine the correct dose for intramuscular administration 2. to compare the frequency of antibody formation after intramuscular administration of native E.coli asparaginase and PEG-asparaginase during two treatment courses in the treatment of childhood lymphoblastic leukemia Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- PEG-asparaginase
- How many people
- 85 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2005to Dec 2013
- Phase
- Phase 4
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1-17 years
- Newly diagnosed ALL (high intensive)
- Treated according to the NOPHO-2000 protocol
- Treated at one of the Nordic pediatric oncology centers
Who cannot join
- <1 year and >18 years
- Newly diagnosed ALL other than high intensive
- Not treated according to the NOPHO-2000 protocol
- Not treated at one of the Nordic pediatric oncology centers
- Allergy to the contents
- Pancreatitis (Active or earlier)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Pediatrics, Skejby Hospital
Aarhus, Aarhus N, 8200
Birgitte K Albertsen, M.D. PhD, +45 89495566 ext. 6732, bka@farm.au.dk
Henrik Schrøder, M.D. PhD, +45 89496712, hsa@sks.aaa.dk
About this study
Official title: PEG-asparaginase During Two Treatment Courses in the Treatment of Childhood Acute Lymphoblastic Leukemia
The purpose of this study is
- to determine the correct dose for intramuscular administration
- to compare the frequency of antibody formation after intramuscular administration of native E.coli asparaginase and PEG-asparaginase during two treatment courses in the treatment of childhood lymphoblastic leukemia
Read the detailed description
Asparaginase is used in the treatment of childhood lymphoblastic leukemia. Approximately 1/3 of the patients develops blocking antibodies against native E.coli asparaginase during the second exposure, so that they do not benefit from treatment and thus may have a worse prognosis.
PEG-asparaginase is less immunogenic so that fewer patients may develop antibodies during the second exposure.
There is no published study about the antibody formation after treatment of children with PEG-asparaginase during two treatment courses.
The first part of the study is a description of the pharmacokinetics of PEG-asparaginase after intramuscular administration in order to determine the correct dose.
The second part of the study is a comparison of antibody formation during two treatment courses after intramuscular administration og native E.coli asparaginase and PEG-asparaginase.
Other side effects than antibodies will be registered during treatment with PEG-asparaginase. Finally comparison of the 5-year EFS between the groups (native E.coli asparaginase and PEG-asparaginase as well as patients who have and have not developed antibodies) will be evaluated.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- PEG-asparaginase
- Keywords
- Asparaginase, intramuscular administration, Silent antibodies, Childhood acute lymphoblastic leukemia, Side effects, 5-year EFS
- 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.
PEG-asparaginaseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the dose that secures sufficient treatment during 14 days
Determination of the frequency of antibody formation during treatment with PEG-asparaginase during two treatment courses
Secondary outcomes (1)
Comparison of 5-year EFS between groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJun 2005
- Study completionDec 2013 (estimated)
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 Acute Lymphoblastic 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordic Society for Pediatric Hematology and Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Medac, Hamburg, Germany, Danish Child Cancer Foundation
- Investigators
- Henrik Schrøder, M.D. PhD, Study director, Department of Pediatrics, Skejby Hospital, Denmark and member of the Scientific Commmittee in NOPHO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192673
- Sponsor's protocol ID
- 2005-000658-56
- Other IDs
- 20040177, 2004-41-4276, 2005
- Status last verified
- Sep 2009
- First submitted
- 11 Sep 2005
- Last updated
- 30 Sep 2009
- Results posted
- No
Publications
Albenberg L, Brensinger CM, Wu Q, Gilroy E, Kappelman MD, Sandler RS, Lewis JD. A Diet Low in Red and Processed Meat Does Not Reduce Rate of Crohn's Disease Flares. Gastroenterology. 2019 Jul;157(1):128-136.e5. doi: 10.1053/j.gastro.2019.03.015. Epub 2019 Mar 11.
PubMed 30872105
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEG-asparaginase During Two Treatment Courses in the Treatment of Childhood Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT00192673
- Acronym / sponsor ID
- 2005-000658-56
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Asparaginase, intramuscular administration, Silent antibodies, Childhood acute lymphoblastic leukemia, Side effects, 5-year EFS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Nordic Society for Pediatric Hematology and OncologyUniversity, hospital or other
- Collaborators
- Medac, Hamburg, Germany, Danish Child Cancer Foundation
- Study start
- Jun 2005
- Study completion
- Dec 2013 (estimated)
- First posted
- 19 Sep 2005 (estimated)
- 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.
The purpose of this study is
- to determine the correct dose for intramuscular administration
- to compare the frequency of antibody formation after intramuscular administration of native E.coli asparaginase and PEG-asparaginase during two treatment courses in the treatment of childhood lymphoblastic leukemia
Detailed description
Asparaginase is used in the treatment of childhood lymphoblastic leukemia. Approximately 1/3 of the patients develops blocking antibodies against native E.coli asparaginase during the second exposure, so that they do not benefit from treatment and thus may have a worse prognosis.
PEG-asparaginase is less immunogenic so that fewer patients may develop antibodies during the second exposure.
There is no published study about the antibody formation after treatment of children with PEG-asparaginase during two treatment courses.
The first part of the study is a description of the pharmacokinetics of PEG-asparaginase after intramuscular administration in order to determine the correct dose.
The second part of the study is a comparison of antibody formation during two treatment courses after intramuscular administration og native E.coli asparaginase and PEG-asparaginase.
Other side effects than antibodies will be registered during treatment with PEG-asparaginase. Finally comparison of the 5-year EFS between the groups (native E.coli asparaginase and PEG-asparaginase as well as patients who have and have not developed antibodies) will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 1-17 years
- Newly diagnosed ALL (high intensive)
- Treated according to the NOPHO-2000 protocol
- Treated at one of the Nordic pediatric oncology centers
Key exclusion criteria (6 listed)
- <1 year and >18 years
- Newly diagnosed ALL other than high intensive
- Not treated according to the NOPHO-2000 protocol
- Not treated at one of the Nordic pediatric oncology centers
- Allergy to the contents
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 |
|---|---|---|
| PEG-asparaginase | Drug | – |
Primary outcome
Determination of the dose that secures sufficient treatment during 14 days
Determination of the frequency of antibody formation during treatment with PEG-asparaginase during two treatment courses
1 secondary outcome
Comparison of 5-year EFS between groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2009.
- Derived from this study: PubMed 30872105Albenberg L, Brensinger CM, Wu Q, Gilroy E, Kappelman MD, Sandler RS, Lewis JD. A Diet Low in Red and Processed Meat Does Not Reduce Rate of Crohn's Disease Flares. Gastroenterology. 2019 Jul;157(1):128-136.e5. doi: 10.1053/j.gastro.2019.03.015. Epub 2019 Mar 11.
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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.
Henrik Schrøder, M.D. PhD study director
Department of Pediatrics, Skejby Hospital, Denmark and member of the Scientific Commmittee in NOPHO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PEG-asparaginase in people with Acute Lymphoblastic Leukemia, run by Nordic Society for Pediatric Hematology and Oncology 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 4 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: status not confirmed, as of the sponsor's last update on 30 Sep 2009. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birgitte K Albertsen, M.D., PhD (+45 89495566 ext. 6732, bka@farm.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the dose that secures sufficient treatment during 14 days. The study lists 2 primary outcomes in all. 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 NCT00192673, 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 30 Sep 2009; AzTrials last refreshed its copy on 6 Nov 2026.