Naive T Cell Deplete Grafts for GVHD Prevention in Non-Malignant Diseases

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT07660783
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Autoimmune Cytopenia
  • Bone Marrow Failure
  • Hemoglobinopathies
  • Hemophagocytic Lymphohistiocytosis (HLH)
  • Immune Dysregulation
  • Non Malignant Disorders
  • Primary Immune Deficiency (PID)

Eligibility Criteria

Sex
ALL
Age
6 Months - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • ALLOGENEIC CD34+ ENRICHED AND CD45RA- DEPLETED PBSCs — BIOLOGICAL
    CD34-selected graft with CD45RA- depleted peripheral blood stem cells given to patients with Non-Malignant Diseases

Study Details

This phase II trial investigates how well a naive T cell depleted graft work for the reduction of graft versus host disease in patients with non-malignant diseases requiring hematopoietic cell transplantation. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.

Key Dates

Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2031
Completion
Sep 30, 2035

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Arm A (HLA-Haploidentical or mismatched unrelated donor)
    Conditioning regimen for HLA-Haploidentical or mismatched unrelated donor consisting of Cyclophosphamide (50 mg/kg x1 day), Fludarabine 35 mg/m2/day x 5 days, Thiotepa (5 mg/kg/day x 2 days), TBI (200 cGy x 2). Tacrolimus starting Day -1, MMF D0-35.
  • Other: Arm B (HLA-matched related or matched unrelated donor )
    Conditioning regimen for HLA-matched related or matched unrelated donor consisting of Cyclophosphamide (50 mg/kg x1 day), Fludarabine (30 mg/m2/day x 5 days), Thiotepa (5 mg/kg/day x 2 days), TBI (200 cGy x 2). Tacrolimus starting Day -1, MMF D0-35.

Primary Outcome Measure

GVHD-free Survival [ Time Frame: 1 year post-transplant ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Fred Hutchinson Cancer CenterSeattleWashington98109-
Seattle Children's HospitalSeattleWashington98105-

Find similar trials in Seattle, WA

By research site
Fred Hutchinson Cancer Center· Seattle, WASeattle Children's Hospital· Seattle, WA

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