Acute Lymphoblastic LeukemiaNCT01094392
Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)
An observational study of Acute Lymphoblastic Leukemia, run by Aarhus University Hospital at 4 sites in Denmark.
Trial summary
Asparaginase is an important drug in the treatment of childhood leukemia. One of the rare but severe side effects to the treatment is thrombosis in or outside the central nervous system. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- How many people
- 65 participants
- Where
- 4 sitesDenmark
- Study dates
- Mar 2010to 10 Oct 2018
- 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 and young adults (age 1-17.9 years) newly diagnosed with ALL in the Nordic Countries and treated according to the Nordic ALL-protocol NOPHO ALL-2008. Written informed consent has been obtained
Who may be able to join
- Childhood ALL, eligible to receive standard risk or intermediate risk therapy as described in the protocol, written informed consent has been obtained
Who cannot join
- No allergic reactions to PEG-asparaginase
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Aalborg Hospital
Aalborg, 9000
Department of Pediatrics, Skejby Hospital
Aarhus, 8200
Department of Pediatrics, Rigshospitalet
Copenhagen, 2100
University Hospital in Odense
Odense, 5000
About this study
Official title: Influence on Hemostasis During Prolonged Asparaginase Treatment in Childhood and Adolescent ALL
Asparaginase is an important drug in the treatment of childhood leukemia. One of the rare but severe side effects to the treatment is thrombosis in or outside the central nervous system.
The aim of this study is to investigate and describe the influence on the coagulation parameters during prolonged treatment with asparaginase.
Hopefully this knowledge will help to foresee the risk of thrombosis and thus making it possible to prevent these.
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- ALL, PEG-asparaginase, prolonged treatment, Thrombosis, Central venous line, Echocardiography
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Thrombosis
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 |
|---|---|---|
| treatment every 6th week during 6 months | Not described | |
| treatment every 2nd week during 6 months | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the coagulation parameters
The study is a prospective and descriptive study. Levels of coagulation parameters will be analyzed using Two Sample T-Test and the levels of asparaginase in serum will be analyzed by Chi2 test.
Measured: December 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startMar 2010
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 65 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, Ph.D. M.D., Principal investigator, Department of Pediatrics, Skejby Hospital, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094392
- Sponsor's protocol ID
- Hemostasis-NOPHO
- Status last verified
- Mar 2016
- First submitted
- 17 Mar 2010
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence on Hemostasis During Prolonged Asparaginase Treatment in Childhood and Adolescent ALL
- ClinicalTrials.gov ID
- NCT01094392
- Acronym / sponsor ID
- Hemostasis-NOPHO
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- ALL, PEG-asparaginase, prolonged treatment, Thrombosis, Central venous line, Echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 29 Mar 2010 (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.
Asparaginase is an important drug in the treatment of childhood leukemia. One of the rare but severe side effects to the treatment is thrombosis in or outside the central nervous system.
The aim of this study is to investigate and describe the influence on the coagulation parameters during prolonged treatment with asparaginase.
Hopefully this knowledge will help to foresee the risk of thrombosis and thus making it possible to prevent these.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment every 6th week during 6 months | – | – |
| treatment every 2nd week during 6 months | – | – |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and young adults (age 1-17.9 years) newly diagnosed with ALL in the Nordic Countries and treated according to the Nordic ALL-protocol NOPHO ALL-2008. Written informed consent has been obtained
Key inclusion criteria (1 listed)
- Childhood ALL, eligible to receive standard risk or intermediate risk therapy as described in the protocol, written informed consent has been obtained
Key exclusion criteria (1 listed)
- No allergic reactions to PEG-asparaginase
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 coagulation parameters
Time frame: December 2016
The study is a prospective and descriptive study. Levels of coagulation parameters will be analyzed using Two Sample T-Test and the levels of asparaginase in serum will be analyzed by Chi2 test.
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 13 Jan 2021.
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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, Ph.D. M.D. principal investigator
Department of Pediatrics, Skejby Hospital, Aarhus, Denmark
4 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 4 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 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 coagulation parameters (time frame: December 2016). 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 13 Jan 2021.