acute lymphoblastic leukemia (ALL) or biphenotypic leukemia MedDRA version: 14.1 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Antithymocyte immunoglobulin (rabbit)
Concentration unit: mg milligram(s)
Concentration number: 15-
Pharmaceutical Form: Solvent for pa
Sponsors
A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Austria, Belgium, Denmark, Germany, Italy, Portugal, United Kingdom
Outcome results
None listed