Safety and Effectiveness of Blinatumomab Combined with Autologous Stem Cell Transplantation for Adults with B-cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating a new treatment approach for adults with B-cell Acute Lymphoblastic Leukemia B-ALL who may not have a suitable donor for allogeneic stem cell transplantation or refuse it. The study focuses on using a combination of blinatumomab, a medication known to clear minimal residual disease MRD, and autologous hematopoietic stem cell transplantation auto-HSCT. This sandwich strategy aims to reduce relapse rates and improve leukemia-free survival and overall survival, while addressing treatment-related mortality concerns seen in traditional methods. Participants first receive induction chemotherapy followed by two cycles of consolidation chemotherapy, including high-dose cytarabine plus pegaspargase, with or without tyrosine kinase inhibitors, and methotrexate plus pegaspargase, again with or without tyrosine kinase inhibitors. After this, they are treated sequentially with blinatumomab. Stem cell mobilization and collection occur 6 to 8 weeks after the first blinatumomab infusion, followed by autologous stem cell transplantation. Starting three months post-transplant, participants receive maintenance treatment with blinatumomab every three months for four cycles. A long-term follow-up period of two years is conducted to monitor outcomes. During the study, participants undergo regular monitoring of minimal residual disease using flow cytometry and gene sequencing. Safety and efficacy are assessed by tracking leukemia-free survival, overall survival, and adverse events over four years. Various laboratory tests and heart and lung function assessments are used to ensure participant safety. The study spans from treatment through a two-year follow-up, with data collected on survival rates and treatment-related mortality to understand the impact of this new consolidation therapy strategy.

Blinatumomab and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL