Condition category
Cancer
Date applied
21/07/2006
Date assigned
21/07/2006
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

Event-free survival

Secondary outcome measures

Survival

Overall trial start date

01/01/2006

Overall trial end date

19/05/2013

Reason abandoned

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

academic

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes