Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Rare Diseases

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Immunologic Deficiency Syndromes

Primary Myelofibrosis

Hematologic Diseases

Syndrome

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Lymphosarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Melphalan

Busulfan

Thiotepa

Mesna

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Protective Agents

Total Body Irradiation 1200 cGy of 150 cGy over 4 or 5 days, days -5 or -4 to -1 Fludarabine 30 mg/m2/day x 3 days, days -6, -5, -4 Stem Cell Infusion, day 0 Post- Stem Cell Infusion Cyclophosphamide 50 mg/kg/day x 2 days, days +3 and +4 Mesna 50 mg/kg/day x 2 days, days +3 and +4

Fludarabine 25 mg/m2/day x 5 days, days -6, -5, -4, -3, -2 Busulfan 130 mg/m2/day x 4 days, days -6, -5, -4, -3 Pre-Stem Cell Infusion Cyclophosphamide 14.5 mg/kg/day x 2 days, days -3 and -2 Pre-Stem Cell Infusion Mesna 14.5 mg/kg/day x 2 days, days -3 and -2 Stem Cell Infusion, day 0 Post-Stem Cell Infusion Cyclophosphamide 50 mg/kg/day x 2 days, days +3 and +4 Post-Stem Cell Infusion Mesna 50 mg/kg/day x 2 days, days +3 and +4

Fludarabine 30 mg/m2/day x 5 days, days -6 to -2 Melphalan 140 mg/m2/day x 1 day, day -2 Stem Cell Infusion, day 0 Post-Stem Cell Infusion Cyclophosphamide 50 mg/kg/day x 2 days, days +3 and +4 Post-Stem Cell InfusionMesna 50 mg/kg/day x 2 days, days +3 and +4

Fludarabine 30 mg/m2/day x 5 days, days -6 to -2 Pre-Stem Cell Infusion Cyclophosphamide 14.5 mg/kg/day x 2 days, days -3 and -2 Pre-Stem Cell InfusionMesna 14.5 mg/kg/day x 2 days, days -3 and -2 Total Body Irradiation 200 cGy, day -1 Stem Cell Infusion, day 0 Post-Stem Cell Infusion Cyclophosphamide 50 mg/kg/day x 2 days, day +3 and +4 Post-Stem Cell Infusion Mesna 50 mg/kg/day x 2 days, day +3 and +4

Fludarabine 30 mg/m2/day x 5 days, days -6 to -2 Thiotepa 8 mg/kg, day -3 Melphalan 140 mg/m2/day x 1 day, day -2 Stem Cell Infusion, day 0 Post-Stem Cell Infusion Cyclophosphamide 50 mg/kg/day x 2 days, days +3 and +4 Post-Stem Cell InfusionMesna 50 mg/kg/day x 2 days, days +3 and +4

Total Body Irradiation 1200 cGy

Cyclophosphamide given prior to the stem cell infusion

Pre-Stem Cell Infusion Cyclophosphamide

Mesna given prior to the stem cell infusion

Pre-Stem Cell Infusion Mesna

Stem Cell Infusion

Cyclophosphamide given after the stem cell infusion

Post-Stem Cell Infusion Cyclophosphamide

Post-Stem Cell Infusion Mesna

Jeffrey Andolina, MD

This study will be a single-center treatment protocol, designed to validate the process of related donor haploidentical-SCT at the Wilmot Cancer Institute Blood and Marrow Transplant Unit.

This study will be a single-center treatment protocol with five possible preparative regimens, designed to validate the process of related donor haploidentical-SCT at the Wilmot Cancer Institute Blood and Marrow Transplant Unit. Enrolled patients will receive chemotherapy +/- radiation as a pre-transplant conditioning regimen. Patients will then receive haploidentical stem cells, either bone marrow or mobilized peripheral blood, followed by GvHD prophylaxis that will include cyclophosphamide. Multiple data points will be collected prior to, during, and following transplantation to ensure safety of the process and to evaluate the stated objectives.

URMC Related Haplo-identical Donor BMT

Haploidentical Donor Hematopoietic Stem Cell Transplantation

The date of engraftment of ANC is the first of 3 consecutive days of ANC of 500 or higher. The date of engraftment of platelets is the first of 3 consecutive days of platelet counts of 20,000 or higher in the absence of platelet transfusions for at least 7 days prior.

The percentage of patients who fail to engraft ANC will be tabulated as well as the percentage of patients who have primary engraftment of ANC but whose graft then fails as evidenced by pancytopenia and failure of bone marrow function.

Assess the presence and date of onset of acute GvHD based on the criteria published by Przepiorka et al., Bone Marrow Transplant 1995; 15(6):825-8 as used by the Center for International Blood \& Marrow Transplant Research.

Assess the severity of acute GvHD based on the criteria published by Przepiorka et al., Bone Marrow Transplant 1995; 15(6):825-8 as used by the Center for International Blood \& Marrow Transplant Research.

Calculate the percentage of patients who develop chronic graft-versus-host disease based on Sullivan KM, Blood 1981; 57:267 as used by the Center for International Blood \& Marrow Transplant Research.

Assess the severity of chronic GvHD in patients who develop chronic graft-versus-host disease based on Sullivan KM, Blood 1981; 57:267 as used by the Center 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 minimally at 100 days. 6 months, and yearly following the infusion of stem cells for as long as the patient survives and remains disease-free.

Document the time to relapse of the disease for which the patient was Minimally assessments will be performed at 100 days. 6 months, and yearly following the infusion of stem cells for as long as the patient survives and remains disease-free.

Evaluate immune reconstitution by measurement of immunoglobulins (IgG, IgA, and IgM), assessment of infections, and lymphocyte analysis

University of Rochester

Medical Director, Pediatric BMT

Nutritional and Metabolic Diseases

Anemia

Metabolic Diseases

Leukemia

Anemia, Aplastic

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Bone Marrow Failure Disorders

Pancytopenia

Chronic Graft Versus Host Disease

Aplastic Anemia

Acute Graft Versus Host Disease

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 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
URMC Related Haplo-identical Donor BMT	NCT02660281	Hematological D... Immune Deficien... Solid Tumors Myelofibrosis Multiple Myelom... Lymphoma	Total Body Irra... Fludarabine Pre-Stem Cell I... Pre-Stem Cell I... Busulfan Melphalan Stem Cell Infus... Post-Stem Cell ... Post-Stem Cell ... Thiotepa	6 Months - 75 Years	University of Rochester
URMC Related Haplo-identical Donor BMT	NCT02660281	Hematological D... Immune Deficien... Solid Tumors Myelofibrosis Multiple Myelom... Lymphoma	Total Body Irra... Fludarabine Pre-Stem Cell I... Pre-Stem Cell I... Busulfan Melphalan Stem Cell Infus... Post-Stem Cell ... Post-Stem Cell ... Thiotepa	6 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
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

Spots Global Cancer Trial Database for total body irradiation 1200 cgy