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…
ID
Bron
Verkorte titel
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Recombinant ASNase instead of regular ASNase Medac during induction therapy.
Algemeen / deelnemers
P.O. Box 2060
Rob Pieters
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636691
rob.pieters@erasmusmc.nl
Wetenschappers
P.O. Box 2060
Rob Pieters
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636691
rob.pieters@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Previously untreated ALL;
2. Moprhological proof of ALL; bone marrow > 25%blasts;
3. Age 1-18 years;
4. Informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL363 |
| NTR-old | NTR402 |
| Ander register | : N/A |
| ISRCTN | ISRCTN75734403 |