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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT07819396
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Acute Biphenotypic Leukemia
  • Acute Leukemia
  • Acute Leukemia of Ambiguous Lineage
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Acute Undifferentiated Leukemia
  • Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Burkitt Leukemia
  • Burkitt Lymphoma
  • Chronic Myeloid Leukemia, BCR-ABL1 Positive
  • Lymphoblastic Lymphoma
  • Mast Cell Leukemia
  • Mixed Phenotype Acute Leukemia
  • Myelodysplastic Syndrome

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic CD34+-enriched and CD45RA-depleted PBSCs — BIOLOGICAL
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Cyclophosphamide — DRUG
    Given IV
  • Fludarabine — DRUG
    Given IV
  • Total-Body Irradiation — RADIATION
    Undergo total-body irradiation

Study Details

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.

Key Dates

First listed
Sep 14, 2026
Start date
Jan 1, 2027
Status verified
Sep 2026
Primary completion
Jun 1, 2031
Completion
Jun 1, 2031

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (CD34-selected graft with CD45RA-depleted PBSC)
    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.

Primary Outcome Measure

Graft versus host disease (GVHD) relapse-free survival [ Time Frame: At 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Phuong Vo, MD
[email protected]
206-667-2749
Phuong Vo, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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