Actively Recruiting
Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases
Led by Fred Hutchinson Cancer Center · Updated on 2026-01-22
54
Participants Needed
1
Research Sites
431 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
N
National Cord Blood Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 6 months to �3C= 65 years at time of consent.
- Acute myelogenous leukemia in first or second complete remission with less than 5% marrow blasts.
- Acute lymphoblastic leukemia in first or second complete remission with high-risk features or persistent minimal residual disease.
- Other acute leukemias of ambiguous lineage or mixed phenotype in morphologic remission with less than 5% blasts.
- Chronic myeloid leukemia in first chronic phase after failure or intolerance to tyrosine kinase inhibitor therapy.
- Myelodysplastic syndromes/myeloproliferative disorders without myelofibrosis with less than 10% bone marrow myeloblasts and adequate neutrophil count.
- High-risk non-Hodgkin lymphoma in complete remission by PET/CT.
- Blastic plasmacytoid dendritic cell neoplasm in morphologic remission.
- Karnofsky score �3E= 70% for adults or Lansky score �3E= 50% for children.
- Adequate kidney, liver, lung, and heart function as defined by specified laboratory and clinical measures.
- Hematopoietic Cell Transplantation Comorbidity index �3C= 5 for adults.
- Umbilical cord blood graft matched at 4-6 HLA antigens with required cell dose.
You will not qualify if you...
- Diagnosis of myelofibrosis or malignancy with moderate-severe bone marrow fibrosis.
- Persistent central nervous system involvement at screening.
- Prior checkpoint inhibitor therapy within 12 months.
- More than two prior stem cell transplants or one recent autologous transplant within 12 months.
- Prior allogeneic transplantation.
- Prior radiation therapy preventing safe total body irradiation.
- Active uncontrolled infection at transplantation.
- HIV infection.
- Inadequate performance status or organ function.
- Pregnancy or breastfeeding.
- Unable to give informed consent or comply with study procedures.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
A
Ann Dahlberg
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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