RecruitingNot ApplicableNCT01962636

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

Sponsor

Masonic Cancer Center, University of Minnesota

Enrollment

200 participants

Start Date

Dec 1, 2016

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia Follicular Lymphoma Small Lymphocytic Lymphoma Myelofibrosis Acute Myeloid Leukemia (AML)Chronic Myelogenous Leukemia Plasma Cell Leukemia Lymphoplasmacytic Lymphoma Myelodysplasia Marginal Zone B-Cell Lymphoma Acute Lymphocytic Leukemia (ALL)

Summary

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).

Eligibility

Max Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a bone marrow transplant using umbilical cord blood from a donor, with a full-strength (myeloablative) preparation regimen, for people with blood cancers or serious blood disorders who need a transplant but do not have a perfectly matched donor. **You may be eligible if...** - You have been diagnosed with a blood cancer (such as leukemia or lymphoma) or a serious blood disorder (such as aplastic anemia or myelodysplastic syndrome) - A bone marrow or stem cell transplant has been recommended as your best treatment option - You do not have a fully matched related or unrelated donor available - You are healthy enough to withstand a full-strength preparation regimen - You are between 0 and 55 years old (age limits may vary by condition) **You may NOT be eligible if...** - You have significant organ damage (heart, liver, kidneys, or lungs) - You have active, uncontrolled infections including HIV - You have had a prior stem cell transplant - You are pregnant - Your disease is not in an appropriate stage for transplant 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

DRUGFludarabine

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

DRUGCyclophosphamide

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

RADIATIONTotal Body Irradiation

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

DRUGCyclosporine A

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.

DRUGMycophenylate mofetil

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.

BIOLOGICALUmbilical cord blood

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.