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Antineoplastic Agents

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All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

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Protective Agents

Full Intensity TBI-based Conditioning Total Body Irradiation 1200 cGy in fractions of 150 cGy days -8 or -7 to -4 Cyclophosphamide 60 mg/kg/day x 2 doses days -3 and -2 Mesna 60 mg/kg/day with 20% loading dose with first Cyclophosphamide followed by continuous infusion over 24 hours x 2 doses \[to be completed 24 hours after final Cyclophosphamide dose\] followed by Cord Blood Infusion Other names: TBI/Cy

Full Intensity, Chemotherapy Conditioning Busulfan days -7 to -4 Recipients \<5 years - 1 mg/kg/dose x 16 doses every 6 hours Recipients \>/= 5 years - 0.8 mg/kg/dose x 16 doses every 6 hours Cyclophosphamide 60 mg/kg/day x 2 doses days -3 and -2 Mesna 60 mg/kg/day with 20% loading dose with first Cyclophosphamide followed by continuous infusion over 24 hours x 2 doses \[to be completed 24 hours after final Cyclophosphamide dose\] followed by Cord Blood Infusion Other names: Bu/Cy

Reduced Intensity Chemotherapy Fludarabine 30 mg/m2/day x 5 doses days -6 to -2 Melphalan 140 mg/m2/day x 1 dose day -2 Cord Blood Infusion Other names: Flu/Mel

Fludarabine 40 mg/m2/day x 5 doses days -6 to -2 Cyclophosphamide 50 mg/kg/day x 1 dose day -6 Mesna 50 mg/kg/day with 20% loading dose with Cyclophosphamide dose followed by continuous infusion over 24 hours x 1 dose \[to be completed 24 hours after Cyclophosphamide dose\] Total Body Irradiation 200 cGy in a single fraction day -1 Cord Blood Infusion Other names: Flu/Cy/TBI

Total Body Irradiation 1200 cGy in 8 fractions

Total Body Irradiation 1200 cGy

Total Body Irradiation 200 cGy in one fraction

Total Body Irradiation 200 cGy

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

Intravenous infusion of cord blood stem cells

Cord Blood Infusion

Jane L Liesveld, MD

Michael W Becker, MD

This study is a single-center, treatment protocol with 4 possible preparative regimens, designed to validate the process of umbilical cord blood stem cell transplantation at our institution.

This study is a single-center treatment protocol with four possible preparative regimens, designed to validate the process of umbilical cord blood stem cell transplantation at our institution. Enrolled patients will receive chemotherapy +/-total body radiation as a pre-transplant conditioning regimen. Patients will then receive cord blood stem cells followed by GvHD prophylaxis that will include Tacrolimus and Mycophenolate Mofetil, or Cyclosporin A and Methylprednisolone. Multiple data points will be collected prior to, during, and following transplantation to ensure safety of the process and to evaluate the stated objectives.

Umbilical Cord Blood Transplantation From Unrelated Donors

The date of engraftment of ANC is the first of 3 consecutive days of ANC of 500 or higher based on daily CBC and Differential Counts. The date of engraftment of platelets is the first of three consecutive days of platelet counts of 20,000 or higher in the absence of platelet transfusions for a t least 7 days prior.

The percentage of patients who fail to initially engraft ANC will be tabulated as well as the percentage of patients who have primary engraftment of ANC but whose graft fails as evidenced by pancytopenia, failure of bone marrow function and loss of donor chimerism following initial engraftment of ANC.

Routine physical exams, liver function tests, and clinical history of diarrhea and upper GI symptoms will be used to assess the presence of, the maximum severity of and the date of onset of Acute GvHD based on the criteria published by Przepioka et al., Bone Marrow Transplant 1995; 15(6):825-8 as used by the Center for International Blood \& Marrow Transplant Research. The percentage of patients developing symptoms of acute graft-versus-host disease will be tabulated.

Assess the presence of and the maximum severity of and the date of onset of chronic GvHD based on Sullivan KM, Blood 1981;57-267 as used by the Cneter for International Blood \& Marrow Transplant Research.

Document and update the length of time a subject survives without recurrence of the disease for which they were transplanted at 30 days, 100 days, 6 months and yearly following the infusion of cord blood stem cells for as long as the subjects survive and remain disease-free.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Umbilical Cord Blood Transplantation From Unrelated Donors	NCT03016806	Acute Leukemia Immune Deficien... Congenital Hema... Metabolism Diso... Aplastic Anemia Myelodysplastic... Chronic Leukemi... Lymphoma Multiple Myelom... Solid Tumor	Total Body Irra... Total Body Irra... Cyclophosphamid... Mesna Cord Blood Infu... Busulfan Fludarabine Melphalan	2 Months - 75 Years	University of Rochester
Umbilical Cord Blood Transplantation From Unrelated Donors	NCT03016806	Acute Leukemia Immune Deficien... Congenital Hema... Metabolism Diso... Aplastic Anemia Myelodysplastic... Chronic Leukemi... Lymphoma Multiple Myelom... Solid Tumor	Total Body Irra... Total Body Irra... Cyclophosphamid... Mesna Cord Blood Infu... Busulfan Fludarabine Melphalan	2 Months - 75 Years	University of Rochester

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