Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)

This phase II trial investigates two strategies and how well they work for the reduction of graft versus host disease in patients with acute leukemia or MDS in remission. 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

Trial Details

NCT ID
NCT03970096
Phase
PHASE2
Sponsor
Fred Hutchinson Cancer Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Total-Body Irradiation
  • Thiotepa
  • Fludarabine
  • Tacrolimus
  • Allogeneic CD34+-enriched and CD45RA-depleted PBSCs
  • Methotrexate
Locations (sample)
  • Tampa, Florida, United States|27.94752,-82.45843
  • Pittsburgh, Pennsylvania, United States|40.44062,-79.99589
  • Seattle, Washington, United States|47.60621,-122.33207

Key Eligibility Criteria

  • Patients who are considered appropriate candidates for myeloablative, TBI-containing allogeneic hematopoietic stem cell transplantation and have on…
  • Acute lymphocytic leukemia (ALL) in first or subsequent morphological remission (\< 5% marrow blasts by morphology).
  • Acute myeloid leukemia (AML) in first or subsequent morphological remission (\< 5% marrow blasts by morphology).
  • Other acute leukemia or related neoplasm (including but not limited to 'mixed phenotype' 'biphenotypic', 'acute undifferentiated' or 'ambiguous lin…

For full eligibility, visit ClinicalTrials.gov.

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