Actively Recruiting
Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults and Pediatrics
Led by Fred Hutchinson Cancer Center · Updated on 2026-01-22
54
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the use of umbilical cord blood transplant combined with chemotherapy drugs cyclophosphamide, fludarabine, and total-body irradiation (TBI) for patients with high-risk hematologic diseases. The purpose is to study how well this treatment works to stop cancer and abnormal cell growth and to support bone marrow recovery. This phase II trial also investigates the use of cyclosporine and mycophenolate mofetil after transplant to prevent immune reactions against the patient's normal cells. Patients are assigned to one of two treatment groups based on age and receive different conditioning regimens before the umbilical cord blood transplant (UCBT). Arm I includes patients aged 6 months to 30 years receiving fludarabine, cyclophosphamide, and high-dose TBI, followed by UCBT. Arm II includes patients 6 months to 65 years receiving fludarabine, cyclophosphamide, thiotepa, and middle-intensity TBI before UCBT. All patients receive graft-versus-host disease (GVHD) prevention drugs cyclosporine and mycophenolate mofetil for several weeks after transplant. Participants undergo blood and bone marrow sample collection, diagnostic imaging including echocardiography or MUGA scans, and clinical assessments before and during the study. Follow-up visits occur at day 180, 1 year, and 2 years after treatment. The main outcome measured is overall survival at 1 year, with additional monitoring of engraftment, GVHD incidence, transplant-related mortality, relapse, and other safety and immune response factors.
CONDITIONS
Brief 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 65 years at time of consent.
- Diagnosis of acute myelogenous leukemia in complete remission with less than 5% marrow blasts at transplant.
- Diagnosis of acute lymphoblastic leukemia in high-risk first remission or beyond with specific molecular or cytogenetic features.
- Other acute leukemias of ambiguous lineage or mixed phenotype with less than 5% blasts.
- Chronic myeloid leukemia in first chronic phase after failure or intolerance to tyrosine kinase inhibitor therapy.
- Myelodysplastic syndromes and myeloproliferative disorders without myelofibrosis, with less than 10% bone marrow blasts and ANC above 0.2.
- High-risk non-Hodgkin lymphoma in remission.
- Blastic plasmacytoid dendritic cell neoplasm in morphologic remission.
- Karnofsky score 70% or higher for adults; Lansky score 50% or higher for children.
- Adequate kidney, liver, lung, and heart function within specified limits.
- Hematopoietic Cell Transplantation Comorbidity Index of 5 or less for adults.
- Umbilical cord blood graft matched at 4-6 HLA antigens per selection criteria.
You will not qualify if you...
- Diagnosis of myelofibrosis or malignancy with moderate to severe bone marrow fibrosis.
- Persistent central nervous system involvement at screening.
- Use of checkpoint inhibitors within the past 12 months.
- More than one prior stem cell transplant or recent autologous transplant within 12 months.
- Prior allogeneic transplantation.
- Prior radiation therapy that prevents safe delivery of total body irradiation.
- Active uncontrolled infection at time of transplant.
- HIV infection.
- Inadequate performance status or organ function outside specified limits.
- Pregnancy or breastfeeding.
- Inability to give informed consent or comply with treatment and follow-up protocols.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for diagnostic imaging, echocardiography or MUGA, and bone marrow aspirate
Duration - Approximately 2 weeks of conditioning and transplantation, with immunosuppressive treatment continuing up to day 100 and tapering through day 101
Participants receive myeloablative conditioning with chemotherapy drugs and total-body irradiation, followed by umbilical cord blood transplantation and graft-versus-host disease prophylaxis.
Daily visits during conditioning and transplantation; frequent visits up to day 100 for medication administration and monitoring
Duration - Up to 2 years after treatment
Participants are monitored after treatment completion for survival, graft function, graft-versus-host disease, and other health outcomes.
Visits at day 180, 1 year, and 2 years post-treatment
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
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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