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
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 hypothesis | 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. |
| Condition | 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 |
| Overall study end date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 366 Days |
| Sex | Both |
| Target number of participants | 500 |
| Participant inclusion criteria | 1. Aged less than 366 days 2. Acute lymphoblastic leukaemia |
| Participant exclusion criteria | Prior therapy for leukaemia (except emergency treatment). |
| Recruitment start date | 01/01/1999 |
| Recruitment end date | 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 |
