Clinical trial NCT00192673: Poly(Ethylene Glycol)(PEG)-Asparaginase During Two Treatment Courses
Official title: PEG-asparaginase During Two Treatment Courses in the Treatment of Childhood Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Lymphoblastic Leukemia
Keywords: Asparaginase
intramuscular administration
Silent antibodies
Childhood acute lymphoblastic leukemia
Side effects
5-year EFS
Lead sponsor: Nordic Society for Pediatric Hematology and Oncology
Sponsor class: OTHER
Collaborators: name: Medac, Hamburg, Germany
name: Danish Child Cancer Foundation
First posted: 2005-09-19
Enrollment: 85
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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 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)

Primary outcomes:
measure: Determination of the dose that secures sufficient treatment during 14 days
measure: Determination of the frequency of antibody formation during treatment with PEG-asparaginase during two treatment courses
Secondary outcomes:
measure: Comparison of 5-year EFS between groups
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Pediatrics, Skejby Hospital
state: Aarhus N
Study officials:
affiliation: Department of Pediatrics, Skejby Hospital, Denmark and member of the Scientific Commmittee in NOPHO
name: Henrik Schrøder, M.D. PhD
role: STUDY_DIRECTOR
References:
citation: Albenberg L, Brensinger CM, Wu Q, Gilroy E, Kappelman MD, Sandler RS, Lewis JD. A Diet Low in Red and Processed Meat Does Not Reduce Rate of Crohn's Disease Flares. Gastroenterology. 2019 Jul;157(1):128-136.e5. doi: 10.1053/j.gastro.2019.03.015. Epub 2019 Mar 11.