Adult Acute Myeloid Leukemia Clinical Trial
Official title:
Phase II Study of Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia in First Remission
RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that
were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells from a
donor can make an immune response against the body's normal cells. Giving total-body
irradiation together with fludarabine, thiotepa, and antithymocyte globulin before transplant
may stop this from happening.
PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in
treating patients with acute myeloid leukemia in remission.
OBJECTIVES:
Primary
- Determine the safety and antileukemia activity of haploidentical allogeneic peripheral
blood stem cell transplantation in patients with high-risk acute myeloid leukemia in
first remission.
Secondary
- 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 this
regimen.
- 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
regimen.
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
years.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 2.2 years.
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