Study of a Pediatric-Inspired Chemotherapy Regimen with Venetoclax and Immunotherapy for Adults Aged 14 to 60 with Ph-Negative Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating a pediatric-inspired chemotherapy regimen combined with venetoclax and immunotherapy in adults aged 14 to 60 years newly diagnosed with Philadelphia chromosome-negative Acute Lymphoblastic Leukemia Ph-negative ALL. This open-label, non-randomized cohort study aims to improve survival outcomes by integrating immunotherapy into a proven pediatric-inspired backbone, building on previous promising results with venetoclax and chemotherapy. The studys primary focus is on Event-Free Survival and minimal residual disease MRD-negative complete remission rates after induction therapy. Participants receive one of two induction regimens based on their disease characteristics VDCLPV for patients with CD22-negative or CD22-positive B-ALL, or 2VIP for CD22-positive B-ALL patients with at least 20% blasts, especially those over 55 years old. Following induction, patients undergo consolidation therapy according to the IH-2022 pediatric-inspired protocol, which includes multiple chemotherapy drugs. Immunotherapy with blinatumomab is optional, given in 1 to 4 cycles alternating with chemotherapy. Maintenance therapy includes monthly MM regimen and a VP plus venetoclax regimen every three months. Central nervous system prophylaxis is provided via intrathecal injections or cranial irradiation, and stem cell transplantation may be considered for high-risk patients or those with positive MRD. During the study, participants undergo regular assessments including MRD evaluation by flow cytometry and next-generation sequencing at induction and at 12 weeks. Researchers monitor outcomes such as complete remission rates, overall survival, relapse-free survival, and cumulative relapse incidence up to five years. Safety and tolerability are evaluated throughout treatment phases, with long-term follow-up to assess event-free survival. Participants organ function, performance status, and adherence to contraception for those of childbearing potential are also monitored. The total participation duration spans from induction through maintenance and follow-up periods as defined in the protocol.

Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia