RT Journal Article T1 A pediatric regimen for adolescents and young adults with Philadelphia chromosome-negative acute lymphoblastic leukemia: Results of the ALLRE08 PETHEMA trial. A1 Ribera, Josep-Maria A1 Morgades, Mireia A1 Montesinos, Pau A1 Tormo, Mar A1 Martínez-Carballeira, Daniel A1 González-Campos, José A1 Gil, Cristina A1 Barba, Pere A1 García-Boyero, Raimundo A1 Coll, Rosa A1 Pedreño, María A1 Ribera, Jordi A1 Mercadal, Santiago A1 Vives, Susana A1 Novo, Andrés A1 Genescà, Eulàlia A1 Hernández-Rivas, Jesús-María A1 Bergua, Juan A1 Amigo, María-Luz A1 Vall-Llovera, Ferran A1 Martínez-Sánchez, Pilar A1 Calbacho, María A1 García-Cadenas, Irene A1 Garcia-Guiñon, Antoni A1 Sánchez-Sánchez, María-José A1 Cervera, Marta A1 Feliu, Evarist A1 Orfao, Alberto A1 PETHEMA Group, Spanish Society of Hematology K1 acute lymphoblastic leukemia K1 adolescents and young adults K1 pediatric treatment AB Pediatric-based or -inspired trials have improved the prognosis of adolescents and young adults (AYA) with Philadelphia chromosome-negative (Ph-neg) acute lymphoblastic leukemia (ALL). This study reports the results of treatment of the ALLRE08 trial, a full pediatric trial for AYA aged 15-30 years with standard-risk (SR) ALL. From 2008 to 2018, 89 patients (38 adolescents [15-18 years] and 51 young adults [YA, 19-30 years], median age: 20 [15-29] years) were enrolled in the ALLRE08 trial. The complete response (CR) was 95%. Twenty-two patients were transferred to a high-risk (HR) protocol because of poor marrow response on day 14 (n = 20) or high-level of end-induction minimal residual response (MRD ≥ 0.25%, n = 2). Cumulative incidence of relapse (CIR) at 5 years was 35% (95%CI: 23%-47%), with significant differences between adolescents and YA: 13% (4%-28%) vs 52% (34%-67%), P = .012. No treatment-related mortality was observed in 66/66 patients following the ALLRE08 trial vs 3/23 patients moved to a HR trial. The estimated 5-year overall survival (OS) was 74% (95%CI: 63%-85%), with significantly higher rates for adolescents vs YA: 87% (95%CI: 74%-100%) vs 63% (46%-80%), P = .021. Although CIR or OS were lower in patients who were transferred to a HR trial, the differences were not statistically significant (CIR: 34% [21%-47%] vs 37% [14%-61%]; OS: 78% [66%-90%] vs 61% [31%;91%]). A full pediatric trial is feasible and effective for AYA with Ph-neg, SR-ALL, with better results for adolescents than for YA. Outcome of patients with poor early response rescued with a HR trial was not significantly inferior. YR 2020 FD 2020-02-05 LK http://hdl.handle.net/10668/15048 UL http://hdl.handle.net/10668/15048 LA en DS RISalud RD Apr 5, 2025