Interfant 99: International collaborative treatment protocol for infants under one year with acute lymphoblastic leukaemia
| ISRCTN | ISRCTN24251487 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24251487 |
| ClinicalTrials.gov (NCT) | NCT00015873 |
| Protocol serial number | NTR182 |
| Sponsor | Interfant Collaborative Group (Netherlands) |
| Funder | Added as of 24/07/2007: Participating hospitals covered the costs of this trial. |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 18/11/2009
- 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 Childrens Hospital
Dutch Childhood Oncology Group
Pediatric Oncology
P.O. Box 2060, 3000 CB
Rotterdam
3015 GJ
Netherlands
| Phone | +31 (0)10 4636691 |
|---|---|
| rob.pieters@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Interfant 99 |
| Study objectives | A late intensification course (VIMARAM) improves the outcome of infants with acute lymphoblastic leukaemia. |
| Ethics approval(s) | Added as of 24/07/2007: Approval was given before recruitment. |
| Health condition(s) or problem(s) studied | Acute lymphoblastic leukaemia (ALL) |
| Intervention | Interventions amended as of 24/07/2007: Intensification course VIMARAM (a course that includes high-dose cytarabine and methotrexate) Interventions provided at time of registration: Intensification course VIMARAM |
| Intervention type | Other |
| Primary outcome measure(s) |
Event free survival |
| Key secondary outcome measure(s) |
Added as of 24/07/2007: Survival |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 366 Days |
| Sex | All |
| Target sample size at registration | 500 |
| Key inclusion criteria | 1. Aged less than 366 days 2. Acute lymphoblastic leukaemia |
| Key exclusion criteria | Prior therapy for leukaemia (except emergency treatment). |
| Date of first enrolment | 01/01/1999 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus MC-Sophia Childrens Hospital
Rotterdam
3015 GJ
Netherlands
3015 GJ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 21/07/2007 | Yes | No | |
| Results article | results | 29/10/2009 | Yes | No |
