INTERNATIONAL COLLABORATIVE TREATMENT PROTOCOL FOR INFANTS UNDER ONE YEAR WITH ACUTE LYMPHOBLASTIC OR BIPHENOTYPIC LEUKEMIA - INTERFANT 06

Conditions: acute lymphoblastic leukemia (ALL) or biphenotypic leukemia
Therapeutic area: Diseases [C] - Cancer [C04]
MedDRA version: 14.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864

Registration Number: EUCTR2005-004599-19-IT

Lead Sponsor: A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 445

Inclusion Criteria

The criteria for entry to the study are: 1. 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. 3. Informed consent of the parents or other legally authorized guardian of the patient.
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients are excluded from the study if at least one of the following exclusion criteria applies: 1. 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 Objective: 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 .;Primary end point(s): Disease Free Survival (DFS) is the primary endpoint. DFS is defined as the time from randomization to relapse, second malignancy or death, whichever occurs first.

Secondary Outcome Measures