Comparative pharmacokinetics, pharmacodynamics, efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukemia (ALL).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24878

Enrollment

Registered

2005-09-13

Start date

2004-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Recombinant ASNase instead of regular ASNase Medac during induction therapy.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Previously untreated ALL; 2. Moprhological proof of ALL; bone marrow > 25%blasts; 3. Age 1-18 years; 4. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Known allergy to ASNase; 2. General health status according to Karnofsky/Lansky 220 umol/L); 6. Liver insufficiency (bilirubin > 50 umol/L; ASAT and ALAT >5x upper limit of normal; 7. Other current malignancies; 8. Pregnancy, breast feeding; 9. Patients suffering from mental disorders.

Design outcomes

Primary

Measure	Time frame
To determine the ratio of the population geometric means of the 72 hour serum concentration versus time curves (AUC) for the first administration of recombinant asparaginase versus Asparaginase medac.	—

Secondary

Measure	Time frame
1. Trough levels of ASNase activity in serum during subsequent ASNase infusions; 2. Serum and CSF levels of asparagine, aspartic acid, glutamine, glutamic acid; 3. CR rate and MRD status at day 33; 4. Adverse events.	—

Contacts

Public ContactRob Pieters

Erasmus Medical Center, Sophia Children's Hospital, Department of Oncology/Hematology, P.O. Box 2060

rob.pieters@erasmusmc.nl+31 (0)10 4636691

Outcome results