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PEG-asparaginase During Two Treatment Courses in the Treatment of Childhood Acute Lymphoblastic Leukemia

Phase 4
1 Year
14 Years
Open (Enrolling)
Acute Lymphoblastic Leukemia

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Trial Information

PEG-asparaginase During Two Treatment Courses in the Treatment of Childhood Acute Lymphoblastic Leukemia

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

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

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.

Inclusion Criteria:

- 1-17 years

- Newly diagnosed ALL (high intensive)

- Treated according to the NOPHO-2000 protocol

- Treated at one of the Nordic pediatric oncology centers

Exclusion Criteria:

- <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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of the dose that secures sufficient treatment during 14 days

Principal Investigator

Henrik Schrøder, M.D. PhD

Investigator Role:

Study Director

Investigator Affiliation:

Department of Pediatrics, Skejby Hospital, Denmark and member of the Scientific Commmittee in NOPHO


Denmark: Danish Medicines Agency

Study ID:




Start Date:

June 2005

Completion Date:

December 2013

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Asparaginase
  • intramuscular administration
  • Silent antibodies
  • Childhood acute lymphoblastic leukemia
  • Side effects
  • 5-year EFS
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma