Clinical Trial

Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases

Recruiting Phase 2
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Summary
This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine, and total-body irradiation (TBI) works in treating patients with hematologic diseases. Giving chemotherapy, such as cyclophosphamide, fludarabine and thiotepa, and TBI before a donor cord blood transplant (CBT) helps stop the growth of cancer and abnormal cells and helps 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening in patients with high-risk hematologic diseases.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2023-08-22; most recent amendment 2026-07-20.
Status change: Not Yet Recruiting → Recruiting 2024-04-03
Trial Details
NCT Number NCT06013423
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: National Cord Blood Network
Conditions Acute Leukemia of Ambiguous Lineage, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm, Hematopoietic and Lymphatic System Neoplasm, Mixed Phenotype Acute Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasm +2 more
Enrollment 54 participants
Start Date 2024-07-23
Primary Completion 2031-10-31 (estimated)
Study Completion 2032-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-22