Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning with Busulfan, Fludarabine, and Total Body Irradiation

What this Trial Is About

This research focuses on patients needing a second or later allogeneic hematopoietic stem cell transplant (HSCT) with reduced intensity conditioning (RIC) due to insufficient donor-derived engraftment after a previous transplant. It evaluates a treatment regimen combining busulfan, fludarabine, and low-dose total body irradiation (TBI) to promote engraftment in patients with either malignant or non-malignant diseases. The study collects routine clinical data to monitor transplant outcomes without experimental interventions beyond standard care. Patients receive busulfan intravenously on days -8 and -7, fludarabine intravenously from days -6 through -2, and a single 200 cGy dose of total body irradiation on day -1. On day 0, patients undergo stem cell infusion. Keppra is given during busulfan administration as seizure prevention, following the institution's protocol. The treatment targets patients aged 0 to 55 years undergoing second or greater transplants with grafts from matched related or unrelated donors, including cord blood units. Throughout the study, researchers collect and maintain clinical transplant data in databases to track key outcomes such as time to engraftment by day 42, incidence of graft failure, donor chimerism status at day 100 and beyond, and occurrences of acute and chronic graft-versus-host disease. Transplant-related mortality and overall survival rates are also recorded at six months. Patients consent to routine data collection, and no additional experimental procedures are involved. The study duration and follow-up extend through at least one year post-transplant to monitor transplant success and complications.

Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)