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van CCT (UK)


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van CCT (UK)


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


- candidate number1648
- NTR NumberNTR402
- ISRCTNISRCTN75734403
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR13-sep-2005
- Secondary IDsN/A 
- Public TitleComparative pharmacokinetics, pharmacodynamics, efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukemia (ALL).
- Scientific TitleComparative pharmacokinetics, pharmacodynamics, efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukemia (ALL).
- ACRONYMN/A
- hypothesisComparison 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.
- Healt Condition(s) or Problem(s) studiedAcute Lymphoblastic Leukemia
- Inclusion criteria1. Previously untreated ALL;
2. Moprhological proof of ALL; bone marrow > 25%blasts;
3. Age 1-18 years;
4. Informed consent.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2004
- planned closingdate1-nov-2006
- Target number of participants32
- InterventionsRecombinant ASNase instead of regular ASNase Medac during induction therapy.
- Primary outcomeTo 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 outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. Rob Pieters
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Rob Pieters
- Sponsor/Initiator Medac GmbH
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsN/A
- Brief summaryChildren 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.
- Main changes (audit trail)
- RECORD13-sep-2005 - 9-sep-2009


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