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Interfant 99.


- candidate number1313
- NTR NumberNTR182
- ISRCTNISRCTN24251487
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR5-sep-2005
- Secondary IDsN/A 
- Public TitleInterfant 99.
- Scientific TitleInternational collaborative treatment protocol for infants under one year with acute lymphoblastic leukemia.
- ACRONYMInterfant 99
- hypothesisA late intensification course (VIMARAM) improves the outcome of infants with acute lymphoblastic leukemia.
- Healt Condition(s) or Problem(s) studiedAcute Lymphoblastic Leukemia
- Inclusion criteria1. Age < 366 days;
2. Acute lymphoblastic leukemia.
- Exclusion criteriaPrior therapy for leukemia (except emergency treatment).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-1999
- planned closingdate1-jan-2006
- Target number of participants500
- InterventionsIntensification course VIMARAM.
- Primary outcomeEvent Free Survival.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr. Rob Pieters
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Rob Pieters
- Sponsor/Initiator Interfant Collaborative Group
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsLancet. 2007 Jul 21;370(9583):240-50.
- Brief summaryOutcome for infant ALL is relatively poor. The Interfant-99 protocol has 3 aims:
1. assess`the outcome of a hybrid therapy schedule including AML elements on an ALL backbone.
2. assess the value of a late intensification course (VIMARAM) including high-dose araC.
3. determine which clinical and biological factors have independent prognostic relevance.
- Main changes (audit trail)
- RECORD29-aug-2005 - 16-okt-2008


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