Contact information
Type
Scientific
Primary contact
Prof Rob Pieters
ORCID ID
Contact details
Erasmus MC-Sophia Childrens Hospital
Dutch Childhood Oncology Group
Pediatric Oncology
P.O. Box 2060
3000 CB
Rotterdam
3015 GJ
Netherlands
+31 (0)10 4636691
rob.pieters@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00015873
Protocol/serial number
NTR182
Study information
Scientific title
Acronym
Interfant 99
Study hypothesis
A late intensification course (VIMARAM) improves the outcome of infants with acute lymphoblastic leukaemia.
Ethics approval
Added as of 24/07/2007: Approval was given before recruitment.
Study design
Multicentre randomised active controlled parallel group trial
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
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
Phase
Not Specified
Drug names
Primary outcome measures
Event free survival
Secondary outcome measures
Added as of 24/07/2007: Survival
Overall trial start date
01/01/1999
Overall trial end date
01/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged less than 366 days
2. Acute lymphoblastic leukaemia
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
500
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
Trial participating centre
Erasmus MC-Sophia Childrens Hospital
Rotterdam
3015 GJ
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Added as of 24/07/2007: Participating hospitals covered the costs of this trial.
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
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17658395
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19657114
Publication citations
-
Results
Pieters R, Schrappe M, De Lorenzo P, Hann I, De Rossi G, Felice M, Hovi L, LeBlanc T, Szczepanski T, Ferster A, Janka G, Rubnitz J, Silverman L, Stary J, Campbell M, Li CK, Mann G, Suppiah R, Biondi A, Vora A, Valsecchi MG, A treatment protocol for infants younger than 1 year with acute lymphoblastic leukaemia (Interfant-99): an observational study and a multicentre randomised trial., Lancet, 2007, 370, 9583, 240-250, doi: 10.1016/S0140-6736(07)61126-X.
-
Results
van der Linden MH, Valsecchi MG, De Lorenzo P, Möricke A, Janka G, Leblanc TM, Felice M, Biondi A, Campbell M, Hann I, Rubnitz JE, Stary J, Szczepanski T, Vora A, Ferster A, Hovi L, Silverman LB, Pieters R, Outcome of congenital acute lymphoblastic leukemia treated on the Interfant-99 protocol., Blood, 2009, 114, 18, 3764-3768, doi: 10.1182/blood-2009-02-204214.