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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00192673
• Other study ID #: 2005-000658-56
• Secondary ID: 200401772004-41-
• Status: Recruiting
• Phase: Phase 4
• First received: September 11, 2005
• Last updated: September 29, 2009
• Start date: June 2005
• Est. completion date: December 2013

Study information

• Verified date: September 2009
• Source: Nordic Society for Pediatric Hematology and Oncology
• Contact: Birgitte K Albertsen, M.D., PhD
• Phone: +45 89495566
• Email: bka[@]farm.au.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencySweden: Swedish Medicines AgencyNorway: Norwegian Medicines AgencyFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 14 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• PEG-asparaginase

Locations

Country	Name	City	State
Denmark	Department of Pediatrics, Skejby Hospital	Aarhus	Aarhus N

Sponsors (3)

Lead Sponsor	Collaborator
Nordic Society for Pediatric Hematology and Oncology	Danish Child Cancer Foundation, Medac, Hamburg, Germany

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the dose that secures sufficient treatment during 14 days
Primary	Determination of the frequency of antibody formation during treatment with PEG-asparaginase during two treatment courses
Secondary	Comparison of 5-year EFS between groups