T Cell Depletion for Leukemia

PV
Overseen ByPhuong Vo, MD
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Fred Hutchinson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

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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

Participant ability to provide informed consent
I have MDS with excess blasts and had cytoreductive therapy in the last 3 months.
My Karnofsky performance status is at least 60%.
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Exclusion Criteria

Participant life expectancy < 12 months from co-existing disease other than leukemia or MDS
Donor preexisting immunoreactivity: positive anti-donor cytotoxic crossmatch excluded
Donor preexisting immunoreactivity: positive panel reactive antibody (PRA) > 10% with positive flow cytometric or B- and T-cell cytotoxic crossmatches excluded
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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

Group I: Treatment (CD34-selected graft with CD45RA-depleted PBSC)Experimental Treatment7 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials
583
Recruited
1,341,000+