Text Size

Poly(Ethylene Glycol)(PEG)-Asparaginase During Two Treatment Courses

This study is currently recruiting participants.
Verified September 2009 by Nordic Society for Pediatric Hematology and Oncology
Sponsor:
Collaborators:
Medac, Hamburg, Germany
The Danish Child Cancer Foundation
Information provided by:
Nordic Society for Pediatric Hematology and Oncology
ClinicalTrials.gov Identifier:
NCT00192673
First received: September 11, 2005
Last updated: September 29, 2009
Last verified: September 2009
History of Changes
  Purpose

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

Condition Intervention Phase
Acute Lymphoblastic Leukemia
 Drug: PEG-asparaginase
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PEG-asparaginase During Two Treatment Courses in the Treatment of Childhood Acute Lymphoblastic Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nordic Society for Pediatric Hematology and Oncology:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Comparison of 5-year EFS between groups

Estimated Enrollment: 85
Study Start Date: June 2005
Estimated Study Completion Date: December 2013
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.

  Eligibility

Ages Eligible for Study:   1 Year to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192673

Contacts
Contact: Birgitte K Albertsen, M.D., PhD +45 89495566 ext 6732 bka@farm.au.dk

Locations
Denmark
Department of Pediatrics, Skejby Hospital Recruiting
Aarhus, Aarhus N, Denmark, 8200
Contact: Birgitte K Albertsen, M.D. PhD     +45 89495566 ext 6732     bka@farm.au.dk    
Contact: Henrik Schrøder, M.D. PhD     +45 89496712     hsa@sks.aaa.dk    
Principal Investigator: Henrik Schrøder, M.D. PhD            
Sponsors and Collaborators
Nordic Society for Pediatric Hematology and Oncology
Medac, Hamburg, Germany
The Danish Child Cancer Foundation
Investigators
Study Director: Henrik Schrøder, M.D. PhD Department of Pediatrics, Skejby Hospital, Denmark and member of the Scientific Commmittee in NOPHO
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00192673     History of Changes
Other Study ID Numbers: 2005-000658-56, 20040177, 2004-41-4276
Study First Received: September 11, 2005
Last Updated: September 29, 2009
Health Authority: Denmark: Danish Medicines Agency
Sweden: Swedish Medicines Agency
Norway: Norwegian Medicines Agency
Finland: Finnish Medicines Agency

Keywords provided by Nordic Society for Pediatric Hematology and Oncology:
Asparaginase
intramuscular administration
Silent antibodies
 Childhood acute lymphoblastic leukemia
Side effects
5-year EFS

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Pegaspargase
Asparaginase
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013