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What this study is

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).

What's being tested

  • Total Body Irradiation 1200 cGy

    Intervention · RADIATION

    Total Body Irradiation 1200 cGy in 8 fractions

  • Total Body Irradiation 200 cGy

    Intervention · RADIATION

    Total Body Irradiation 200 cGy in one fraction

  • Cyclophosphamide

    Intervention · DRUG

    50 mg/kg or 60 mg/kg

  • Mesna

    Intervention · DRUG

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

  • Cord Blood Infusion

    Intervention · PROCEDURE

    Intravenous infusion of cord blood stem cells

  • Busulfan

    Intervention · DRUG

    0.8 mg/kg x 16 doses

  • Fludarabine

    Intervention · DRUG

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

  • Melphalan

    Intervention · DRUG

    140 mg/m2

Study details

Sponsor
University of Rochester
Conditions
Acute Leukemia · Immune Deficiency Disorder · Congenital Hematological Disorder · Metabolism Disorder · Aplastic Anemia · Myelodysplastic Syndromes · Chronic Leukemia · Lymphoma · Multiple Myeloma · Solid Tumor
Enrolling
30 people
Starts
2015-06
Est. completion
2027-06
Record
View on ClinicalTrials.gov ↗