Phase II Study of Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia in First Remission
- Determine the safety and antileukemia activity of haploidentical allogeneic peripheral
blood stem cell transplantation in patients with high-risk acute myeloid leukemia in
- Determine the early treatment-related mortality (before day 100) of patients treated
with this regimen.
- Determine the incidence of acute graft-versus-host disease in patients treated with
- Determine the incidence of graft failure in patients treated with this regimen.
- Correlate a mismatch in the expression of the natural killer cell inhibitory receptors
CD158a and CD158b with engraftment and disease recurrence in patients treated with this
OUTLINE: This is a multicenter study.
Patients receive a preparative regimen comprising total-body irradiation twice on day –8;
fludarabine IV over 30 minutes on days –7 to –3; thiotepa IV over 2 hours twice on day –7;
and antithymocyte globulin IV over 4-6 hours on days –5 to –2. Patients undergo
haploidentical allogeneic peripheral blood stem cell transplantation on day 0.
Patients are followed at day 100, at least monthly for 2 years, and then periodically for 3
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 2.2 years.
Primary Purpose: Treatment
Mark R. Litzow, MD
United States: Federal Government