No registrations found.
ID
Source
Brief title
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Children with newly diagnosed ALL receive either recombinant asparaginase or regular asparaginase during induction therapy (8 doses). Single centre, randomised, double-blind, parallel-group, phase II study. Aim is to compare pharmacokinetics, pharmacodynamics, efficacy and safety.
Study objective
Comparison of pharmacokinetics, pharmacodynamics, efficacy and safety of recombinant asparaginase(ASNase) versus Asparaginase medac during induction treatment in children with de novo ALL and to demonstrate that any clinical important difference to the disadvantage of recombinant ASNase is unlikely.
Study design
N/A
Intervention
Recombinant ASNase instead of regular ASNase Medac during induction therapy.
P.O. Box 2060
Rob Pieters
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636691
rob.pieters@erasmusmc.nl
P.O. Box 2060
Rob Pieters
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636691
rob.pieters@erasmusmc.nl
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
1. Known allergy to ASNase;
2. General health status according to Karnofsky/Lansky <40%;
3. Pre-existing coagulopathy (e.g. hemophilia);
4. Pre-existing pancreatitis;
5. Kidney insufficiency (creatinine > 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL363 |
| NTR-old | NTR402 |
| Other | : N/A |
| ISRCTN | ISRCTN75734403 |