Pilot Study of AlphaBeta T-cell and B-cell Depleted Allogeneic Transplantation Followed by Blinatumomab Treatment for High-Risk B-Cell Acute Lymphoblastic Leukemia in Children, Adolescents, and Young Adults

What this Trial Is About

Researchers are evaluating a new treatment approach for children, adolescents, and young adults up to 25 years old with high-risk B-cell acute lymphoblastic leukemia B-ALL. This study aims to reduce leukemia relapse and improve survival after hematopoietic cell transplantation HCT by using a special type of transplant combined with the drug blinatumomab. The study also seeks to lower treatment-related complications and late effects, adjusting pre-transplant conditioning based on minimal residual disease MRD status using high throughput sequencing. Participants receive an alpha-beta T-cell and B-cell depleted transplant. Those who test positive for MRD by sequencing but negative by flow cytometry undergo a myeloablative conditioning regimen including total body irradiation TBI, followed by the transplant and a 28-day continuous blinatumomab infusion starting 100 days after transplant if no significant graft-versus-host disease GVHD is present. Participants who are MRD negative by both methods receive a reduced intensity conditioning regimen before the same type of transplant and post-transplant blinatumomab infusion under similar conditions. Throughout the study, participants will be monitored for their ability to receive blinatumomab, treatment-related side effects, survival, disease relapse, graft success or failure, GVHD occurrence, and patient-reported outcomes. Assessments include clinical exams, laboratory tests, and minimal residual disease measurements at multiple points up to one year after transplantation. The total planned enrollment is approximately 25 patients, with follow-up lasting at least one year post-transplant.

Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT