Comparative pharmacokinetics, pharmacodynamics, efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukaemia (ALL)
| ISRCTN | ISRCTN75734403 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75734403 |
| Secondary identifying numbers | NTR402 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 07/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Rob Pieters
Scientific
Scientific
Erasmus MC-Sophia Children's Hospital Rotterdam
Dutch Childhood Oncology Group
Pediatric Oncology
P.O. Box 2060
Rotterdam
3015 GJ
Netherlands
| Phone | +31 (0)10 4636691 |
|---|---|
| rob.pieters@erasmusmc.nl |
Study information
| Study design | Single centre, randomised, double-blind, parallel-group, phase II study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Acute lymphoblastic leukaemia (ALL) |
| Intervention | Recombinant ASNase instead of regular ASNase Medac during induction therapy. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Recombinant asparaginase |
| Primary outcome measure | 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 study start date | 01/11/2004 |
| Completion date | 01/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 32 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 01/11/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus MC-Sophia Children's Hospital Rotterdam
Rotterdam
3015 GJ
Netherlands
3015 GJ
Netherlands
Sponsor information
Medac GmbH (Germany)
Industry
Industry
Theaterstrasse 6
Wedel
D-22880
Germany
"ROR" |
https://ror.org/05e0gzh77 |
|---|
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 15/12/2008 | Yes | No |
