Study of Pediatric-Inspired Chemotherapy Combined With Venetoclax for Teens and Adults Aged 14 to 60 With Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia

What this Trial Is About

This research aims to improve treatment for adolescent and adult patients aged 14 to 60 years with newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia Ph- ALL. While pediatric-inspired regimens have improved outcomes, relapse remains a significant challenge. Venetoclax, an oral drug that targets B-cell lymphoma 2, is being studied alongside this regimen to enhance remission rates and reduce relapse, potentially improving overall survival. Participants receive a combination of chemotherapy drugs including vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, and venetoclax during induction therapy. Venetoclax dosing increases over the induction period, with additional dosing if bone marrow blasts remain high. Following induction, consolidation therapy continues with a multi-drug pediatric-inspired chemotherapy regimen combined with venetoclax. Maintenance therapy involves monthly treatments with vincristine, mercaptopurine, methotrexate, and prednisone for up to 3 years for males and 2.5 years for females. During the study, participants undergo bone marrow aspiration on day 14 of induction and are monitored for minimal residual disease MRD using flow cytometry after 4 weeks. Researchers will assess remission rates, survival outcomes, relapse-free survival, and adverse events over several years. Safety and disease status are closely followed up to 5 years post-registration to evaluate long-term effects and treatment success.

Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia