Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma

Leukemia

Leukemia, Lymphoid

Hematologic Neoplasms

Hodgkin Disease

Hematologic Diseases

Lymphosarcoma

Hodgkin Lymphoma

Acute Graft Versus Host Disease

Romiplostim at the assigned dose will be administered subcutaneously (SQ) once a week for 6 weeks (i.e. 6 doses) unless platelet count exceeds 100 x 10\^9/L and at least 4 doses of therapy were given.After the initial dose, subsequent doses will be administered within a window of +/- 3 days.

Romiplostim at the assigned dose will be administered subcutaneously (SQ) once a week for 6 weeks. The dose will be assigned at the time of subject registration. This is a dose escalation to determine the maximum tolerated dose. The doses include 4 mcg/kg/dose, 6 mcg/kg/dose, 8 mcg/kg/dose, and 10 mcg/kg/dose.

Romiplostim

Margaret MacMillan, MD, MSc, FRCPC

This is a single institution, phase I dose escalation study of weekly romiplostim post umbilical cord blood transplantation in patients who fail to achieve platelet engraftment by day +30. Engraftment is defined as a platelet count ≥ 20 x 109/L on 3 consecutive measurements without transfusion for 7 days. Romiplostim is administered at the assigned dose as 6 weekly injections beginning by day +42 post transplant. Up to 4 dose levels (4, 6, 8, and 10 mcg/kg/dose) will be evaluated with the maximum tolerated dose (MTD) of romiplostim determined by using the Continual Reassessment Method (CRM). The goal of this CRM will be to identify 1 of the 4 dose levels which corresponds to the desired maximum toxicity rate of 20% or less.

Safety of Romiplostim (Nplate®) Following UCBT

Safety of Romiplostim (Nplate®) in Patients Who Have Failed to Achieve Platelet Engraftment Following Umbilical Cord Blood Transplant

Measured by number of patients who have failed to achieve platelet engraftment by day +28 after a myeloablative or nonmyeloablative umbilical cord blood transplant (UCBT)

Average speed of platelet recovery in patients who have failed to achieve platelet engraftment.

Incidence of clinically significant bleeding episodes and number of platelet transfusions.

Masonic Cancer Center, University of Minnesota

Symptoms and General Pathology

Infections

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, Large B-Cell, Diffuse

Leukemia, Prolymphocytic

Preleukemia

Myelodysplastic Syndromes

Lymphoma, B-Cell

Primary Myelofibrosis

Burkitt Lymphoma

Waldenstrom Macroglobulinemia

Leukemia, Plasma Cell

Lymphoma, Non-Hodgkin

Syndrome

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Myeloproliferative Disorders

Bone Marrow Diseases

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Precancerous Conditions

Chronic Graft Versus Host Disease

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Non Lymphoblastic Leukemia

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

Mantle Cell Lymphoma

Follicular Lymphoma

B-cell Lymphoma

Marginal Zone Lymphoma

Diffuse Large B-Cell Lymphoma

Plasma Cell Leukemia

Chronic Myeloproliferative Disorders

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Infective Agents

Dermatologic Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Cyclosporine

Cyclosporins

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Enzyme Inhibitors

Clotrimazole

Miconazole

Antifungal Agents

Calcineurin Inhibitors

The myeloablative preparative regimen will consist of cyclophosphamide (CY), fludarabine (FLU) and fractionated total body irradiation (TBI)followed by umbilical cord blood transplant. Immunosuppressive Cyclosporine and Mycophenylate Mofetil (MMF) will be administered pre- and post UCBT.

25 mg/m\^2 IV of Fludarabine will be given over 1 hour on days -8, -7, and -6 pre-UCB transplant.

60 mg/kg IV of Cyclophosphamide will be given over 2 hours on days -7 and -6 pre-UCB transplant.

165 cGy of total body irradiation will be given twice a day on days -4, -3, -2, and -1.

Total Body Irradiation

Cyclosporine A (CSA) will start day -3 and will be administered PO/IV maintaining a trough level between 200 and 400 ng/mL. For adults the initial dose will be 2.5 mg/kg IV over 1 hour every 12 hours. For children \< 40 kg the initial dose will be 2.5 mg/kg IV over 1 hour every 8 hours.

Cyclosporine A

Mycophenylate mofetil (MMF) 3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 or 3 doses. Pediatric patient (\<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours beginning day -3.

Mycophenylate mofetil

Pre-medications and UCB infusion will be per current institutional policies/guidelines. The infusion of the first UCB unit should begin within 15 minutes, and no later than 30 minutes after arrival on the Unit. If 2 units are used, both cords will be infused within 30-60 minutes of each other as deemed clinically safe by the BMT attending or designee.

Umbilical cord blood

Claudio Brunstein, MD

This is a treatment guideline for an unrelated umbilical cord blood transplant (UCBT) using a myeloablative preparative regimen for the treatment of hematological diseases, including, but not limited to acute leukemias. The myeloablative preparative regimen will consist of cyclophosphamide (CY), fludarabine (FLU) and fractionated total body irradiation (TBI).

This is a study to collect routine clinical data from UCBT using unrelated single or double UCB units as an alternative, non-HLA-matched stem cell source for patients with hematological diseases.

* data collection from transplant preparative therapy consisting of treatments with chemotherapeutic regimens and total body irradiation.
* data collection from umbilical cord blood selection and infusion.
* data collection from standard supportive disease and transplant related care.

Pre- and post-transplant medication, UCB selection and infusion, supportive care, and follow-up will be according to the current University of Minnesota BMT guidelines.

An average of 18 patients are expected to be treated on this protocol per year.

Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for Hematological Diseases

Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for the Treatment of Hematological Diseases

The number of patients that are still living 1 year after UCBT.

Number of subjects with neutrophil engraftment at day 42 post UCBT.

Number of patients with platelet engraftment at 1 year post UCBT.

Pattern of chimerism after transplant. Chimerism will be plotted with box-plots and described over time.

Cumulative incidence of graft failure after UCBT.

Cumulative incidence will be used to estimate acute graft versus host disease 100 days after UCBT.

Cumulative incidence will be used to estimate chronic GVHD at 1 year post UCBT.

Cumulative incidence will be used to estimate transplant related mortality at 6 months post UCBT.

Kaplan-Meier curves will be used to estimate disease-free survival at 1 and 2 years post UCBT.

Kaplan-Meier curves will be used to estimate overall survival at 1 and 2 years post UCBT.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety of Romiplostim (Nplate®) Following UCBT	NCT02046291	Hematologic Mal...	Romiplostim	18 Years -	Masonic Cancer Center, University of Minnesota
Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for Hematological Diseases	NCT01962636	Acute Myeloid L... Acute Lymphocyt... Chronic Myeloge... Plasma Cell Leu... Myelofibrosis Myelodysplasia Chronic Lymphoc... Small Lymphocyt... Marginal Zone B... Follicular Lymp... Lymphoplasmacyt... Mantle-Cell Lym... Prolymphocytic ... Diffuse Large B... Lymphoblastic L... Burkitt's Lymph... Non-Hodgkin Lym... Multiple Myelom...	Fludarabine Cyclophosphamid... Total Body Irra... Cyclosporine A Mycophenylate m... Umbilical cord ...	- 55 Years	Masonic Cancer Center, University of Minnesota
Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for Hematological Diseases	NCT01962636	Acute Myeloid L... Acute Lymphocyt... Chronic Myeloge... Plasma Cell Leu... Myelofibrosis Myelodysplasia Chronic Lymphoc... Small Lymphocyt... Marginal Zone B... Follicular Lymp... Lymphoplasmacyt... Mantle-Cell Lym... Prolymphocytic ... Diffuse Large B... Lymphoblastic L... Burkitt's Lymph... Non-Hodgkin Lym... Multiple Myelom...	Fludarabine Cyclophosphamid... Total Body Irra... Cyclosporine A Mycophenylate m... Umbilical cord ...	- 55 Years	Masonic Cancer Center, University of Minnesota

Spots Global Cancer Trial Database for umbilical cord transplant