This phase 1 trial will investigate the safety and effectiveness of Thiotepa, Busulfan, and Fludarabine (TBF) conditioning regimen with post-transplant cyclophosphamide (PTCy) in HLA-matched related or unrelated donor allogeneic stem cell transplantation (alloSCT).
Age 50-70 years old or
Age 18-49 and unfit for a conventional myeloablative conditioning regimen per the treating physician
Acute lymphocytic leukemia (ALL) in first or subsequent morphological remission (<5% marrow blasts by morphology).
Acute myeloid leukemia (AML) in first or subsequent morphological remission (<5% marrow blasts by morphology) with or without hematologic recovery.
Poor performance status with Karnofsky Score <70%
Center for International Blood and Marrow Transplant Research (CIBMTR) hematopoietic cell transplant co-morbidity index (HCT-CI) score >5
Patients with active central nervous system (CNS) involvement refractory to intrathecal chemotherapy and/or standard craniospinal radiation.
Patients who are positive for HIV-1, HIV-2, HTLV1 or HTLV2.
Sawa Ito, MD
Lead sponsor
University of Pittsburgh
Sponsor institution