NCT03016806

Umbilical Cord Blood Transplantation From Unrelated Donors

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 2 Months – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to determine how long it takes for the engraftment (recovery of blood cell counts) of umbilical cord stem cells and also how often engraftment of umbilical cord stem cells transplanted from an unrelated donor fails. Another purpose will be to document the rate of disease-free survival and the rate of relapse (a return of your disease or syndrome) as well as the incidence and severity of graft versus host disease (GvHD) following cord blood stem cell transplantation. GvHD is a complication of stem cell transplants in which white blood cells from the transplanted tissue (graft) attack the transplant recipient's body (host).

Detailed description

PRIMARY OBJECTIVES: I. Determine the kinetics of engraftment of umbilical cord blood (UCB) following transplantation into unrelated individuals. II. Determine the incidence of non-engraftment and secondary graft failure when unrelated donor UCB cells are administered to patients receiving myeloablative, reduced intensity cytoreductive, or non-ablative conditioning regimens together with immunosuppressive therapy. III. Determine the incidence and severity of graft-vs-host disease (GVHD) for patients receiving unrelated donor UCB grafts. IV. Document the overall survival, disease-free-survival, and rates of relapse for UCB transplant recipients. OUTLINE: This is an observational study. Patients undergo a conditioning regimen per standard of care at the discretion of the treating provider, followed by a planned UCB transplantation on study. Patients also have their medical records reviewed for engraftment data on study.

Conditions

• Acute Leukemia
• Immune Deficiency Disorder
• Congenital Hematological Disorder
• Metabolism Disorder
• Aplastic Anemia
• Myelodysplastic Syndromes
• Chronic Leukemia
• Lymphoma
• Multiple Myeloma
• Solid Tumor

Interventions

Type	Name	Description
RADIATION	Total Body Irradiation 1200 cGy	Total Body Irradiation 1200 cGy in 8 fractions
RADIATION	Total Body Irradiation 200 cGy	Total Body Irradiation 200 cGy in one fraction
DRUG	Cyclophosphamide	50 mg/kg or 60 mg/kg
DRUG	Mesna	50 mg/kg or 60 mg/kg plus 10% loading dose
PROCEDURE	Cord Blood Infusion	Intravenous infusion of cord blood stem cells
DRUG	Busulfan	0.8 mg/kg x 16 doses
DRUG	Fludarabine	30 mg/m2/day x 5 or 40 mg/m2/day x 5
DRUG	Melphalan	140 mg/m2

Timeline

• Start date: 2015-06-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2017-01-11
• Last updated: 2025-10-10

Locations

1 site across 1 country: United States