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
Contact information
Prof Rob Pieters
Scientific
Scientific
Erasmus Medical Center
Sophia Children's Hospital
Department of Oncology/Hematology
PO Box 2060
Rotterdam
3015 GJ
Netherlands
| Phone | +31 (0)10 4636691 |
|---|---|
| rob.pieters@erasmusmc.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Interfant-06 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Event-free survival |
| Secondary outcome measures | Survival |
| Overall study start date | 01/01/2006 |
| Completion date | 19/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 1 Year |
| Sex | All |
| Target number of participants | 445 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 19/05/2013 |
Locations
Countries of recruitment
- Netherlands
- United States of America
Study participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
3015 GJ
Netherlands
Sponsor information
Stichting Kinder Oncologie (SKION) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Leyweg 299
Den Haag
2545 CJ
Netherlands
| Phone | +31 (0)70 3674545 |
|---|---|
| info@skion.nl | |
"ROR" |
https://ror.org/01zs6bp63 |
Funders
Funder type
University/education
Erasmus Medical Center (Netherlands)
Government organisation / Universities (academic only)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
