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Complete title: A Multi-center Phase II Study of Selective Depletion of CD45RA+ T cells from Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD
|Research Study Number||2222.00|
|Principal Investigator||Marie Bleakley, MD|
Research Study Description
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 Childrens 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.
Eligibility Criteria (must meet the following to participate in this study)
Eligible for allogeneic hematopoietic stem cell transplantation (HSCT)
Appropriately matched, sibling donor is available
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
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
Known hypersensitivity to tacrolimus
Other exclusion criteria may apply.
Acute Lymphoid Leukemia (ALL); Acute Myeloid Leukemia (AML); Bone Marrow and Hematopoietic Stem Cell Transplant (BMT and HSCT); Hematologic Malignancies; Leukemia; Childhood Cancers, Miscellaneous; Myelodysplastic and Myeloproliferative Syndromes (MDS and
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