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RECRUITING
NCT01962636
NA

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

Sponsor: Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

Any - 55 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2016-12

Completion Date

2028-02

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

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.

Locations (1)

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, United States