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INTERFANT-06. International collaborative treatment protocol for infants under one year of age with acute lymphoblastic or biphenotypic leukemia.


- candidate number2109
- NTR NumberNTR695
- ISRCTNISRCTN12500962
- Date ISRCTN created21-jul-2006
- date ISRCTN requested19-jul-2006
- Date Registered NTR29-mei-2006
- Secondary IDsN/A 
- Public TitleINTERFANT-06. International collaborative treatment protocol for infants under one year of age with acute lymphoblastic or biphenotypic leukemia.
- Scientific TitleINTERFANT-06. International collaborative treatment protocol for infants under one year of age with acute lymphoblastic or biphenotypic leukemia.
- ACRONYMInterfant-06.
- hypothesisThe primary aim of the study is: 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. Secondary aims are: 2. 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. 3. To assess the overall outcome of the Interfant-06 protocol compared to the historical control series, especially the Interfant-99. 4. To assess the outcome of LR, MR and HR patients as compared to the historical control series in Interfant-99. 5. To study which factors have independent prognostic value. 6. To assess the role of SCT in HR patients.
- Healt Condition(s) or Problem(s) studiedAcute Lymfatic Leukemia (ALL), Biphenotypic leukemia
- Inclusion criteria1. Children aged 365 days or less with newly diagnosed acute lymphoblastic leukemia (ALL) or biphenotypic leukemia according to EGIL criteria. Children with 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.
- Exclusion criteria1. Mature 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 these data are not known, the patient is eligible); 3. Age > 365 days; 4. Relapsed ALL; 5. Systemic use of corticosteroids less than 4 weeks before diagnosis. Patients who received corticosteroids by aerosol are eligible for the study.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jan-2006
- planned closingdate1-jan-2012
- Target number of participants445
- InterventionsComparison 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.
- Primary outcomeEvent free survival.
- Secondary outcomeSurvival.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. Rob Pieters
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Rob Pieters
- Sponsor/Initiator Stichting KinderOncologie Nederland (SKION)
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryInfant acute lymphoblastic leukemia (ALL) has a poor prognosis compared to ALL in older children. Becuase it is a rare disease, in 1999 an international collaboration was started to try to improve outcome for infant ALL. Interfant-99 was the first study leading to an event-free survival of 47%. Early bone marrow relapses were the major reason for therapy failure. The interfant-06 study aims to improve therapy by comparing two different early therapy intensifications: two "AML" induction blocks versus protocol Ib given directly after induction therapy in patients with a MLL gene rearrangement. Other aims are: - to assess the outcome of the Interfant-06 protocol compared to the historical control series, especially the Interfant-99. - To study which factors have independent prognostic value. - To assess the role of SCT in patients at high risk for relapse.
- Main changes (audit trail)
- RECORD29-mei-2006 - 24-jul-2006


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