Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Prof Rob Pieters
ORCID ID
Contact details
Erasmus Medical Center
Sophia Children's Hospital
Department of Oncology/Hematology
PO Box 2060
Rotterdam
3015 GJ
Netherlands
+31 (0)10 4636691
rob.pieters@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Interfant-06
Study hypothesis
The primary aim of the study is:
1. To assess the role of an early intensification of two acute myeloid leukaemia (AML)-induction blocks versus protocol Ib directly after induction, in a randomized way in medium-risk (MR) and high-risk (HR) patients
Secondary aims are:
1. To assess the role of an early intensification of two AML induction blocks versus protocol Ib directly after induction, in a randomized way in MR and HR patients, separately
2. To assess the overall outcome of the Interfant-06 protocol compared to the historical control series, especially the Interfant-99 (ISRCTN24251487)
3. To assess the outcome of low-risk (LR), MR and HR patients as compared to the historical control series in Interfant-99
4. To study which factors have independent prognostic value
5. To assess the role of stem cell transplantation (SCT) in HR patient
As of 24/02/2011 the anticipated end date for this trial has been extended from 01/01/2012 to 19/05/2013.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Biphenotypic leukemia, acute lymphoblastic leukemia (ALL)
Intervention
Comparison of early intensification of two AML induction blocks versus protocol Ib directly after induction, in a randomized way in medium risk and high risk patients
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
Event-free survival
Secondary outcome measures
Survival
Overall trial start date
01/01/2006
Overall trial end date
19/05/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children aged 365 days or less with newly diagnosed acute lymphoblastic leukemia (ALL) or biphenotypic leukemia according to European Group for the Immunological Classification of Leukemia (EGIL) criteria. Children with central nervous system (CNS) or testicular leukemia at diagnosis are eligible
2. Morphological verification of the diagnosis, confirmed with cytochemistry and immunophenotyping. In case a bone marrow aspiration results in a dry tap, a trephine biopsy is advised unless it is possible to confirm the diagnosis by peripheral blood examination.
3. Informed consent of the parents or other legally authorized guardian of the patient
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
445
Participant exclusion criteria
1. Mature B-cell acute lymphoblastic leukemia (B-ALL), defined by the immunophenotypical presence of surface immunoglobulines or t(8;14) and breakpoint as in B-ALL
2. The presence of the t(9;22) (q34;q11) or bcr-abl fusion in the leukemic cells (if this data is not known, the patient is eligible)
3. Age >365 days
4. Relapsed ALL
5. Systemic use of corticosteroids less than four weeks before diagnosis. Patients who have received corticosteroids by aerosol are eligible for the study
Recruitment start date
01/01/2006
Recruitment end date
19/05/2013
Locations
Countries of recruitment
Netherlands, United States of America
Trial participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
Sponsor information
Organisation
Stichting Kinder Oncologie (SKION) (The Netherlands)
Sponsor details
Leyweg 299
Den Haag
2545 CJ
Netherlands
+31 (0)70 3674545
info@skion.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Erasmus Medical Center (Netherlands)
Alternative name(s)
Erasmus Medical Center, Erasmus MC
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Netherlands
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
Basic results (scientific)
Publication list