Phase 1 Study of TCR-alphabeta and CD19 Depleted Haploidentical Stem Cell Transplant with Zoledronate for Children and Young Adults with Relapsed or Hard-to-Treat Blood Cancers and High-Risk Solid Tumors

What this Trial Is About

Researchers are evaluating the safety of a specialized stem cell transplant combined with the drug Zoledronate for children and young adults with relapsed or refractory blood cancers or high-risk solid tumors. This phase I trial focuses on using a haploidentical donor peripheral blood stem cell graft that has been depleted of certain immune cells TCR alphabeta and CD19 cells to reduce complications after transplant. Patients with high-risk leukemia receive a strong conditioning regimen including anti-thymocyte globulin, fludarabine, thiotepa, and total body irradiation, while others receive a reduced-intensity conditioning with similar drugs but different dosing. On day 0, patients undergo transplantation with the treated stem cell graft. If the graft has fewer than a set number of stem cells, a second graft may be given. To prevent graft-versus-host disease GVHD, patients with higher immune cell counts receive specific medications like mycophenolate mofetil and tacrolimus. Zoledronate is given intravenously in five doses spaced 28 days apart, starting 28 days after transplant. During the study, participants are closely monitored for signs of acute GVHD within the first 100 days and for graft failure by day 28. Immune system recovery is followed for up to one year. The study uses detailed lab tests, imaging, and clinical assessments to track outcomes and safety. The total participation period includes the transplant, post-transplant drug dosing, and follow-up evaluations over months to assess transplant success and immune function.

Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors