Intensive Conditioning Regimen With Thiotepa, Busulfan, Fludarabine, and Cytarabine for Stem Cell Transplantation in Myeloid Malignancies With Extramedullary Involvement

What this Trial Is About

Researchers are evaluating an intensive conditioning regimen combining thiotepa, busulfan, fludarabine, and cytarabine for patients undergoing allogeneic hematopoietic stem cell transplantation to treat myeloid malignancies with extramedullary involvement. This single-arm, prospective phase II trial aims to assess the regimen's efficacy and safety, focusing on progression-free survival and other post-transplant outcomes. The study is led by Shanghai General Hospital and targets adults aged 18 to 55 with specific myeloid tumor conditions. The treatment involves a conditioning phase starting nine days before the stem cell infusion, with thiotepa given on days -9 and -8, fludarabine and cytarabine from days -7 to -3, and busulfan from days -5 to -3. Donor stem cells are infused on day 0. After transplantation, patients will undergo bone marrow examinations on days 14 and 28, followed by regular checks every 30 days during the first year and every 60 days in the second year. Additional assessments will be performed if relapse is suspected. Participants will be closely monitored for outcomes including progression-free survival at one and two years, overall survival, incidence of acute and chronic graft-versus-host disease, relapse rates, and viral reactivation. The study includes laboratory tests, bone marrow biopsies, and regular clinical evaluations to track health status and treatment effects over time. Follow-up extends up to two years post-transplant to capture long-term outcomes and safety data.

Intensive Conditioning withTHI/Bu/Flu/Ara-C in Allo-HSCT for Myeloid Malignancies With Extramedullary Involvement