Targeted High-dose Irradiation with Donor T Cell Immunotherapy to Improve Stem Cell Transplant in High-risk Acute Leukemia Patients

What this Trial Is About

Researchers are evaluating a specialized treatment for patients with high-risk acute leukemia, including Acute Myeloid Leukemia AML and Acute Lymphoblastic Leukemia ALL. This study focuses on combining a targeted high-dose radiation regimen with an innovative immunotherapy using donor regulatory and conventional T cells. The goal is to improve outcomes for those undergoing hematopoietic stem cell transplantation HSCT. All participants will receive a conditioning treatment using a total marrowlymphoid irradiation TMLI at a dose of 20 Gy. This is followed by the infusion of donor stem cells along with TregTcon adoptive immunotherapy. The donor cells come from family or unrelated donors who are either fully or partially matched to the patients immune system. This approach aims to enhance the effectiveness of the transplant. During the study, participants will be closely monitored for disease status, graft success, and complications such as graft-versus-host disease GvHD. Key assessments include checking the number of patients free from disease two years after transplantation and monitoring engraftment at 45 days. Safety and long-term outcomes will be evaluated over a two-year period. The total involvement duration varies depending on individual progress and response.

Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia