Condition category
Cancer
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
07/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Rob Pieters

ORCID ID

Contact details

Erasmus MC-Sophia Children's Hospital Rotterdam
Dutch Childhood Oncology Group
Pediatric Oncology
P.O. Box 2060
Rotterdam
3015 GJ
Netherlands
+31 (0)10 4636691
rob.pieters@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR402

Study information

Scientific title

Acronym

Study hypothesis

Comparison of pharmacokinetics, pharmacodynamics, efficacy and safety of recombinant asparaginase (ASNase) versus asparaginase medac during induction treatment in children with de novo acute lymphoblastic leukaemia (ALL) and to demonstrate that any clinical important difference to the disadvantage of recombinant ASNase is unlikely.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Single centre, randomised, double-blind, parallel-group, phase II study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acute lymphoblastic leukaemia (ALL)

Intervention

Recombinant ASNase instead of regular ASNase Medac during induction therapy.

Intervention type

Drug

Phase

Not Specified

Drug names

Recombinant asparaginase

Primary outcome measures

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 measures

1. Trough levels of ASNase activity in serum during subsequent ASNase infusions
2. Serum and cerebrospinal fluid (CSF) levels of asparagine, aspartic acid, glutamine, glutamic acid
3. Complete remission (CR) rate and minimal residual disease (MRD) status at day 33
4. Adverse events

Overall trial start date

01/11/2004

Overall trial end date

01/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Previously untreated ALL
2. Morphological proof of ALL; bone marrow greater than 25% blasts
3. Aged 1 - 18 years
4. Informed consent

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

32

Participant exclusion criteria

1. Known allergy to ASNase
2. General health status according to Karnofsky/Lansky less than 40%
3. Pre-existing coagulopathy (e.g. haemophilia)
4. Pre-existing pancreatitis
5. Kidney insufficiency (creatinine greater than 220 umol/l)
6. Liver insufficiency (bilirubin greater than 50 umol/l; aspartate aminotransferase [ASAT] and alanine aminotransferase [ALAT] greater than 5 x upper limit of normal
7. Other current malignancies
8. Pregnancy, breast feeding
9. Patients suffering from mental disorders

Recruitment start date

01/11/2004

Recruitment end date

01/11/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus MC-Sophia Children's Hospital Rotterdam
Rotterdam
3015 GJ
Netherlands

Sponsor information

Organisation

Medac GmbH (Germany)

Sponsor details

Theaterstrasse 6
Wedel
D-22880
Germany

Sponsor type

Industry

Website

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18805963

Publication citations

  1. Results

    Pieters R, Appel I, Kuehnel HJ, Tetzlaff-Fohr I, Pichlmeier U, van der Vaart I, Visser E, Stigter R, Pharmacokinetics, pharmacodynamics, efficacy, and safety of a new recombinant asparaginase preparation in children with previously untreated acute lymphoblastic leukemia: a randomized phase 2 clinical trial., Blood, 2008, 112, 13, 4832-4838, doi: 10.1182/blood-2008-04-149443.

Additional files

Editorial Notes