Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
18/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Interfant Collaborative Group (Netherlands)

Sponsor details

-
Rotterdam
-
Netherlands

Sponsor type

Not defined

Website

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

  1. 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.

  2. 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.

Additional files

Editorial Notes