RecruitingNCT03016806

Umbilical Cord Blood Transplantation From Unrelated Donors


Sponsor

University of Rochester

Enrollment

30 participants

Start Date

Jun 1, 2015

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 2 MonthsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial studies stem cell transplants using donated umbilical cord blood to treat blood cancers and rare immune or metabolic disorders in people who cannot find a closely matched bone marrow donor. **You may be eligible if...** - You have a blood cancer such as leukemia, lymphoma, or multiple myeloma that has come back or did not respond to standard treatment - You have a rare immune system disorder, bone marrow failure, or inherited metabolic disease that can be treated with a stem cell transplant - Your heart, lungs, kidneys, and liver are working well enough to handle the transplant - You are in reasonably good physical condition (able to carry out normal activity) **You may NOT be eligible if...** - A closely matched bone marrow donor (related or unrelated) is available and ready in time - You had a stem cell transplant using your own cells within the past 6 months - You are pregnant or breastfeeding - You have an active, uncontrolled infection - You are HIV positive Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONTotal Body Irradiation 1200 cGy

Total Body Irradiation 1200 cGy in 8 fractions

RADIATIONTotal Body Irradiation 200 cGy

Total Body Irradiation 200 cGy in one fraction

DRUGCyclophosphamide

50 mg/kg or 60 mg/kg

DRUGMesna

50 mg/kg or 60 mg/kg plus 10% loading dose

PROCEDURECord Blood Infusion

Intravenous infusion of cord blood stem cells

DRUGBusulfan

0.8 mg/kg x 16 doses

DRUGFludarabine

30 mg/m2/day x 5 or 40 mg/m2/day x 5

DRUGMelphalan

140 mg/m2


Locations(1)

Wilmot Cancer Institute

Rochester, New York, United States

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NCT03016806


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