The purpose of this trial is to gather real world evidence of treatment outcomes and toxicities of AYA Ph-negative ALL patients in Argentina who receive pediatric-like treatment in first line.~The study primary endpoints are to evaluate survival (event free survival and overall survival) and toxicities of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.~Secondary endpoints are to evaluate survival in patients who underwent allogeneic transplantation in first remission, asparaginase toxicities, and assess central cerebrospinal fluid by flow cytometry.~Every ALL patient diagnosed in our institutions will follow our guidelines with respect to diagnosis procedures.~High-risk (HR) group was defined as presenting high risk cytogenetics/molecular findings and depending on the response achieved at different time points: bad response to prednisone at day 8, ≥ 10% blast in bone marrow on day 15, minimal residual disease (MRD) by flow cytometry ≥0.1% at day 33 and ≥0.01% at day 78 in bone marrow. No-high risk group was defined as those without any high-risk factor.~The chemotherapy regimen included pre-induction phase, induction (phase I and II), consolidation, re-intensification, central nervous system (CNS) prophylaxis and maintenance therapy or ASCT in first remission .~The initial pre-induction phase, where steroids were given for 7 days. Induction therapy, phase IA consisted of weekly vincristine and daunorubicin for 4 weeks, L-Asparaginase for 8 doses or peg-asparaginase for 2 doses and prednisone continuously for 4 weeks. Phase IB consisted cytarabine for 16 doses, cyclophosphamide for 1-2 doses and 6-mercaptopurine for 28 days.~The consolidation phase consisted of 4 doses of methotrexate and 6-mercaptopurine for 56 days for Non-High Risk patients (M phase) and two cycles of three different blocks of high dose multi chemotherapy for HR patients. Re-induction consisted in two phases similar to induction. According to risk and response to treatment, patients will be candidates to maintenance for 18 months or ASCT in first remission.~Minimal residual disease will be evaluated at least on day 33, 78, in consolidation and every thee months during maintenance treatment or previous to ASCT.
This is a multicenter, observational real world clinical trial with prospective follow up that will evaluate the treatment outcome of adolescent and young patients with ph-negative acute lymphoblastic leukemia with first-line pediatric-like protocol in Argentina.