NCT01962636

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Acute Myeloid Leukemia (AML)
• Acute Lymphocytic Leukemia (ALL)
• Chronic Myelogenous Leukemia
• Plasma Cell Leukemia
• Myelofibrosis
• Myelodysplasia
• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma
• Marginal Zone B-Cell Lymphoma
• Follicular Lymphoma
• Lymphoplasmacytic Lymphoma
• Mantle-Cell Lymphoma
• Prolymphocytic Leukemia
• Diffuse Large B Cell Lymphoma
• Lymphoblastic Lymphoma
• Burkitt's Lymphoma
• Non-Hodgkin Lymphoma
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Fludarabine	25 mg/m\^2 IV of Fludarabine will be given over 1 hour on days -8, -7, and -6 pre-UCB transplant.
DRUG	Cyclophosphamide	60 mg/kg IV of Cyclophosphamide will be given over 2 hours on days -7 and -6 pre-UCB transplant.
RADIATION	Total Body Irradiation	165 cGy of total body irradiation will be given twice a day on days -4, -3, -2, and -1.
DRUG	Cyclosporine 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.
DRUG	Mycophenylate 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.
BIOLOGICAL	Umbilical 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.

Timeline

• Start date: 2016-12-01
• Primary completion: 2027-02-01
• Completion: 2028-02-01
• First posted: 2013-10-14
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States