International collaborative treatment protocol for infants under age one with acute lymphoblastic or biphenotypic leukemia

ISRCTN ISRCTN12500962
DOI https://doi.org/10.1186/ISRCTN12500962
Secondary identifying numbers N/A
Submission date
21/07/2006
Registration date
21/07/2006
Last edited
14/07/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-treatment-for-babies-with-acute-lymphoblastic-leukaemia-or-mixed-type-leukaemia

Contact information

Prof Rob Pieters
Scientific

Erasmus Medical Center
Sophia Children's Hospital
Department of Oncology/Hematology
PO Box 2060
Rotterdam
3015 GJ
Netherlands

Phone +31 (0)10 4636691
Email rob.pieters@erasmusmc.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymInterfant-06
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBiphenotypic leukemia, acute lymphoblastic leukemia (ALL)
InterventionComparison 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 typeOther
Primary outcome measureEvent-free survival
Secondary outcome measuresSurvival
Overall study start date01/01/2006
Completion date19/05/2013

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit1 Year
SexBoth
Target number of participants445
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2006
Date of final enrolment19/05/2013

Locations

Countries of recruitment

  • Netherlands
  • United States of America

Study participating centre

Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands

Sponsor information

Stichting Kinder Oncologie (SKION) (The Netherlands)
Hospital/treatment centre

Leyweg 299
Den Haag
2545 CJ
Netherlands

Phone +31 (0)70 3674545
Email info@skion.nl
ROR logo "ROR" https://ror.org/01zs6bp63

Funders

Funder type

University/education

Erasmus Medical Center (Netherlands)
Government organisation / Universities (academic only)
Alternative name(s)
Erasmus Medical Center, Erasmus MC, Erasmus Universitair Medisch Centrum, Erasmus University Medical Center, Universitair Medisch Centrum Rotterdam, Erasmus Universitair Medisch Centrum Rotterdam, EMC
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan