Real-world study of pediatric-like first-line treatment for young adults aged 18 to 40 with Philadelphia-negative acute lymphoblastic leukemia in Argentina

What this Trial Is About

Researchers are gathering real-world evidence on treatment outcomes and toxicities for adolescents and young adults aged 18 to 40 with Philadelphia chromosome-negative acute lymphoblastic leukemia Ph-negative ALL in Argentina. This observational study focuses on patients receiving first-line pediatric-like chemotherapy protocols tailored by risk category, aiming to evaluate survival rates and treatment side effects over three years. It also considers outcomes for those undergoing allogeneic transplantation in first remission and assesses cerebrospinal fluid involvement. The treatment protocol includes several phases a 7-day pre-induction steroid phase induction with weekly vincristine, daunorubicin, asparaginase, and prednisone consolidation with methotrexate and 6-mercaptopurine for non-high-risk patients, or intensive chemotherapy for high-risk patients re-induction similar to induction and either maintenance therapy for 18 months or autologous stem cell transplantation in first remission based on risk and response. Minimal residual disease is monitored at multiple time points during treatment. Participants will be followed prospectively with regular evaluations including flow cytometry of bone marrow and cerebrospinal fluid, toxicity monitoring, and survival assessments for up to 36 months. Researchers will assess event-free survival, overall survival, and treatment toxicities. Data on asparaginase side effects and central nervous system involvement will also be collected. The study spans from diagnosis through follow-up, contributing valuable real-world data on pediatric-like treatment in this patient group.

RWE of Pediatric-like Protocol for AYA Patients With Ph-negative ALL