Risk-Adapted Immuno-Chemotherapy and Stem Cell Transplant for Babies With B-Cell Acute Lymphoblastic Leukemia Diagnosed Within the First Year of Life

What this Trial Is About

Researchers are evaluating a risk-adapted combination of chemotherapy, immunotherapy, and hematopoietic stem cell transplantation HSCT for infants diagnosed with B-linear Acute Lymphoblastic Leukemia ALL within the first year of life. The study stratifies patients into standard, intermediate, and high-risk groups based on genetic markers and minimal residual disease MRD levels after induction therapy. This approach aims to tailor treatment intensity to each patients risk profile to improve outcomes. Treatment varies by risk group and MRD status. Standard risk patients without KMT2A gene rearrangement receive induction therapy with drugs including dexamethasone, vincristine, daunorubicin, and pegasparaginase, followed by consolidation and maintenance if MRD is low. Those with higher MRD levels get a course of blinatumomab and HSCT. Intermediate risk patients receive similar induction but may undergo additional chemotherapy blocks or blinatumomab and HSCT depending on MRD progression. High-risk patients receive induction therapy followed by chemotherapy blocks, blinatumomab, and HSCT regardless of remission status. Participants undergo detailed diagnostic evaluations before therapy, including bone marrow analyses. Treatment response is monitored through MRD levels to guide therapy adjustments. Researchers measure event-free and overall survival at four years, relapse risk at three years, MRD-negative remission rates after induction and consolidation, and mortality related to HSCT. The study spans from diagnosis through treatment and follow-up, with careful monitoring to assess long-term outcomes in this pediatric population.

Combined Immuno-chemotherapy for Patients With B-linear Acute Lymphoblastic Leukemia Diagnosed From 0 to 365 Days of Life (ALL-Baby-2021)