T Cell Depletion for Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial tests how well removing CD45RA positive naive T cells works to prevent graft versus host disease in older patients undergoing standard of care allogeneic hematopoietic stem cell transplantation for the treatment of acute leukemia or myelodysplastic syndrome (MDS). Allogeneic hematopoietic stem cell transplantation is when healthy cells are collected from a donor and infused into a patient to help the patient's bone marrow make more healthy cells and platelets and help destroy any remaining cancer cells. Giving chemotherapy and total-body irradiation before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Removing the T cells from the donor cells before the transplant may stop this from happening. Giving CD45RA positive naive T cell depleted allogenic hematopoietic stem cell transplant may prevent graft versus host disease while treating acute leukemia or myelodysplastic syndrome in older adults.
Who Is on the Research Team?
Phuong Vo, MD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
This trial is for older adults with acute leukemia or myelodysplastic syndrome who are eligible for a stem cell transplant from a donor. Participants should be healthy enough to undergo chemotherapy and radiation before the transplant.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Allogeneic CD34+-enriched and CD45RA-depleted PBSCs
- Cyclophosphamide
- Fludarabine
- Total-Body Irradiation
Trial Overview
The study tests if removing certain immune cells (CD45RA positive naive T cells) from donor stem cells can help prevent graft-versus-host disease after a standard allogeneic stem cell transplant, using chemo and total-body irradiation as preparation.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive cyclophosphamide IV, over 1-2 hours on days -6 and -5, fludarabine IV , over 30 minutes on days -6 to -2 and total body irradiation for 1 treatment on day -1 or 0. Patients receive CD34+ enriched peripheral blood stem cells and CD45RA+ depleted cells IV on day 0. Patients undergo bone marrow aspiration/biopsy, echocardiography, and blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fred Hutchinson Cancer Center
Lead Sponsor
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