Naive T Cell Deplete Grafts for Bone Marrow Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Madhavi Lakkaraja, MD, MPH
Principal Investigator
Fred Hutch Cancer Center
Are You a Good Fit for This Trial?
This trial is for people with non-cancerous blood and immune system disorders, such as bone marrow failure or primary immunodeficiency, who need a stem cell transplant from a donor. Participants should not have active cancer.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- ALLOGENEIC CD34+ ENRICHED AND CD45RA- DEPLETED PBSCs
Trial Overview
The study tests if using donor stem cells that are specially processed to remove certain naive T cells (CD45RA-) can lower the risk of graft versus host disease after transplantation. All participants receive chemotherapy and total-body irradiation before the transplant.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fred Hutchinson Cancer Center
Lead Sponsor
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