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NOT YET RECRUITING
NCT07819396
PHASE2

Depletion of CD45RA Positive Naive T Cells for the Prevention of Graft Versus Host Disease in Older Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Acute Leukemia or Myelodysplastic Syndrome

Sponsor: Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase II Prospective Study Evaluating Selective Depletion of CD45RA⁺ Naïve T Cells (TND) From Peripheral Blood Stem Cell Grafts for the Prevention of Graft-Versus-Host Disease in Older Patients With Acute Leukemia or Myelodysplastic Syndrome Undergoing Allogeneic Hematopoietic Cell Transplantation (HCT)

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2027-01-01

Completion Date

2031-06-01

Last Updated

2026-09-14

Healthy Volunteers

No

Interventions

BIOLOGICAL

Allogeneic CD34+-enriched and CD45RA-depleted PBSCs

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

RADIATION

Total-Body Irradiation

Undergo total-body irradiation

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States