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 number | NCT00015873 |
| Secondary identifying numbers | NTR182 |
- 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
| Study design | Multicentre randomised active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | Event free survival |
| Secondary outcome measures | Added as of 24/07/2007: Survival |
| Overall study start date | 01/01/1999 |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 366 Days |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Interfant Collaborative Group (Netherlands)
Not defined
Not defined
-
Rotterdam
-
Netherlands
Funders
Funder type
Hospital/treatment centre
Added as of 24/07/2007: Participating hospitals covered the costs of this trial.
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 | 21/07/2007 | Yes | No | |
| Results article | results | 29/10/2009 | Yes | No |
