Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes

This phase II trial studies how well donor umbilical cord blood transplant with ex-vivo expanded cord blood progenitor cells (dilanubicel) works in treating patients with blood cancer. Before the transplant, patients will receive chemotherapy (fludarabine, cyclophosphamide and in some cases thiotepa) and radiation therapy. Giving chemotherapy and total-body irradiation before a donor umbilical cord blood 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.

NCT Number	NCT03399773
Lead Sponsor	Fred Hutchinson Cancer Center Collaborators: Nohla Therapeutics, Inc., National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Hematopoietic and Lymphoid Cell Neoplasm, Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts
Enrollment	31 participants
Start Date	2022-05-10
Primary Completion	2025-06-09 (estimated)
Study Completion	2027-04-02 (estimated)
Updated on ClinicalTrials.gov	2026-07-10