Acute Lymphoblastic LeukaemiaNCT01272440
A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia
An observational study of Acute Lymphoblastic Leukaemia, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Asparaginase is an important drug i the treatment of childhood leukaemia. The aim of this project is to study the pharmacokinetics, pharmacodynamics and antibody development and hypersensitivity reactions during prolonged PEG-asparaginase treatment. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Acute Lymphoblastic Leukaemia
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2011to Dec 2015
- Phase
- Observational
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 between 1 and 18 years old, diagnosed ALL and treated according to the NOPHO-ALL 2008 protocol
Who may be able to join
- Children aged between 1 and 18 years old, diagnosed ALL and treated according to the NOPHO-ALL 2008 protocol and who have accepted to participate in this study
Who cannot join
- Children that does not attend the NOPHO-ALL 2008 protocol but receives standard treatment
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Paediatric department, Skejby University hospital
Aarhus, Denmark, 8200
Louise T Henriksen, MD
About this study
Official title: PEG-asparaginase Treatment in the NOPHO ALL-2008 Protocol: Antibody Formation, Pharmacokinetics, Pharmacodynamics and Side Effects.
Asparaginase is an important drug i the treatment of childhood leukaemia.
The aim of this project is to study the pharmacokinetics, pharmacodynamics and antibody development and hypersensitivity reactions during prolonged PEG-asparaginase treatment.
Read more
Study part 1) Asparaginase pharmacokinetics and pharmacodynamics during prolonged PEG-asparaginase treatment: A NOPHO ALL-2008 study
Study part 2) Asparagine depletion in cerebrospinal fluid: A NOPHO ALL-2008 study
Study part 3) A characterization of PEG-asparaginase hypersensitivity in children treated according to the NOPHO ALL 2008 protocol
Perspectives: New knowledge about PEG-asparaginase treatment regarding dosing, dosing interval, adverse effects and EFS, which may lead to improved future therapy
Patients: Children diagnosed with acute lymphoblastic leukaemia in the Nordic Countries
- Conditions
- Acute Lymphoblastic Leukaemia
- Keywords
- PEG-asparaginase, children, pharmacokinetics, antibodies, acute lymphoblastic leukaemia, adverse effects
- 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.
Asparagine depletion
Blood samples and cerebrospinal fluid samples are collected at certain timepoints during 30 weeks of treatment with PEG-asparaginase. They are analyzed for asparagine, asparaginase-enzyme activity and asparaginase-antibodies.These measures tell about the effect of the drug, PEG-asparaginase.
Measured: Up to 30 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukaemiaStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Tram Henriksen, Aarhus University Hospital
- Investigators
- Louise T Henriksen, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272440
- Sponsor's protocol ID
- LTH-1
- Status last verified
- Nov 2013
- First submitted
- 5 Jan 2011
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes