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PEG-asparaginase Treatment in the NOPHO ALL-2008 Protocol: Antibody Formation, Pharmacokinetics, Pharmacodynamics and Side Effects.


N/A
1 Year
18 Months
Open (Enrolling)
Both
Acute Lymphoblastic Leukaemia

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Trial Information

PEG-asparaginase Treatment in the NOPHO ALL-2008 Protocol: Antibody Formation, Pharmacokinetics, Pharmacodynamics and Side Effects.


Inclusion Criteria:



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

Exclusion Criteria:

Children that does not attend the NOPHO-ALL 2008 protocol but receives standard treatment

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Asparagine depletion

Outcome Description:

Bloodsamples and cerebrospinalfluidsamples are collected at certain timepoints during 30 weeks of treatment with PEG-asparaginase. They are analysed for asparagine, asparaginase-enzymeactivity and asparaginase-antibodies.These measures tell about the effect of the drug, PEG-asparaginase.

Outcome Time Frame:

Up to 30 weeks of treatment

Safety Issue:

No

Principal Investigator

Louise T Henriksen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Aarhus University Hospital

Authority:

Denmark: The Danish National Committee on Biomedical Research Ethics

Study ID:

LTH-1

NCT ID:

NCT01272440

Start Date:

January 2011

Completion Date:

December 2012

Related Keywords:

  • Acute Lymphoblastic Leukaemia
  • PEG-asparaginase
  • children
  • pharmacokinetics
  • antibodies
  • acute lymphoblastic leukaemia
  • adverse effects
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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