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

September 29, 2009 updated by: Nordic Society for Pediatric Hematology and Oncology

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

85

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Aarhus N
      • Aarhus, Aarhus N, Denmark, 8200
        • Recruiting
        • Department of Pediatrics, Skejby Hospital
        • Contact:
          • Birgitte K Albertsen, M.D. PhD
          • Phone Number: 6732 +45 89495566
          • Email: bka@farm.au.dk
        • Contact:
          • Henrik Schrøder, M.D. PhD
          • Phone Number: +45 89496712
          • Email: hsa@sks.aaa.dk
        • Principal Investigator:
          • Henrik Schrøder, M.D. PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Comparison of 5-year EFS between groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordic Society for Pediatric Hematology and Oncology

Collaborators

Danish Child Cancer Foundation
Medac, Hamburg, Germany

Investigators

  • Study Director: Henrik Schrøder, M.D. PhD, Department of Pediatrics, Skejby Hospital, Denmark and member of the Scientific Commmittee in NOPHO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

September 30, 2009

Last Update Submitted That Met QC Criteria

September 29, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-000658-56
  • 20040177
  • 2004-41-4276

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe