Study of Pediatric-Based Treatment Protocol for Adults Aged 16 to 50 with Philadelphia-Negative Acute Lymphoblastic Leukemia in Brazil

What this Trial Is About

Researchers are studying adults aged 16 to 50 years who have newly diagnosed Philadelphia-negative acute lymphoblastic leukemia ALL to evaluate the effects of using a pediatric treatment regimen. This prospective registry, conducted at multiple centers in Brazil, aims to see whether applying a BFM-based pediatric protocol incorporating peg-asparaginase can improve event-free survival and overall survival outcomes. The study also focuses on genetic classification, minimal residual disease MRD monitoring, and the assessment of toxicities such as infections, liver damage, and thrombosis in this patient population. Participants will receive a uniform intensive treatment protocol based on pediatric ALL regimens, including drugs like prednisone, vincristine, daunorubicin, peg-asparaginase, intrathecal chemotherapy methotrexate, dexamethasone, cytarabine, cyclophosphamide, cytarabine, mercaptopurine, methotrexate, and doxorubicin. All patients eligible for this intensive protocol are included in a single group without comparison arms. Diagnostic and follow-up samples will be centrally biobanked, and genetic and MRD analyses will be standardized and centralized to ensure consistent evaluation across centers. During the study, patients will be closely monitored with scheduled diagnostic and follow-up assessments, including genetic testing and MRD measurements. Researchers will evaluate several outcomes over four years, such as overall survival, event-free survival, early death rate, complete response rate, relapse incidence, and hematopoietic stem cell transplant rates. The study includes a centralized biobank and standardized laboratory assessments to collect accurate clinical and laboratory data, supporting long-term follow-up and safety evaluations until June 2030.

Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil