Clinical Trial Detail

The purpose of this study is to determine the effects, good or bad, of an experimental type of transplant in people with acute leukemia or advanced myelodysplastic syndromes. This study is being done to see whether or not this type of transplant protects study participants against graft-vs-host disease (GVHD). (GVHD is a complication that can happen after a transplant.)

The type of transplant used in this study is called a selective T-cell depleted transplant. Certain cells (CD45RA+ naive T-cells) will be removed from the donated stem cells in the laboratory after the cells are collected from the donor but before they are given to the study participant. The naïve T cells are thought to cause GVHD.

Participants will receive outpatient treatment at the Seattle Cancer Care Alliance (SCCA) and will be admitted to the University of Washington Medical Center (UWMC) or Seattle Children’s for those parts of their care requiring hospitalization.

All study procedures will be completed by about one year after transplant. After that point we will be monitoring study participants as part of the long-term follow-up program for post-transplant complications.

• Diagnosed with acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML) or advanced myleodysplastic syndrome (MDS)

• Age 14-55

• Eligible for allogeneic hematopoietic stem cell transplantation (HSCT)

• Appropriately matched, sibling donor is available

Other eligibility criteria may apply.

• Pregnant or breast-feeding

• Undergoing second hematopoietic stem cell transplantation (HSCT)

• Central nervous system (CNS) involvement that does not respond to intrathecal chemotherapy and/or standard cranial-spinal radiation

• HIV+

• Uncontrolled infections

• Organ dysfunction

• Known hypersensitivity to tacrolimus

Other exclusion criteria may apply.