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RECRUITING
NCT03016806

Umbilical Cord Blood Transplantation From Unrelated Donors

Sponsor: University of Rochester

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

2 Months - 75 Years

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2015-06

Completion Date

2027-06

Last Updated

2025-10-10

Healthy Volunteers

No

Interventions

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

Locations (1)

Wilmot Cancer Institute

Rochester, New York, United States