NCT01622556

Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies

Phase II Trial of Reduced Intensity Conditioning (RIC) and Allogeneic Transplantation of Umbilical Cord Blood (UCB) From Unrelated Donors in Patients With Hematologic Malignancies

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study to assess the day 180 event free and overall survival after administration of a specified combination of fludarabine, busulfan, Total Body Irradiation (TBI), and thymoglobulin reduced intensity conditioning and 2 unit UCB stem cell transplant in a single institution setting in patients with hematologic malignancies for whom allogeneic transplantation is indicated.

Conditions

• Hematologic Malignancies

Interventions

Type	Name	Description
DRUG	Fludarabine	35 mg/m2 IV/day x 5 days
DRUG	Busulfan	.8 mg/kg IV Q6h x 8 doses
DRUG	Thymoglobulin	1.5 mg/kg/day x 3 days
RADIATION	Total Body Irradiation	150 cGy for 2 days
BIOLOGICAL	Umbilical Cord Blood	Two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient.

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-02-01
• Completion: 2017-01-01
• First posted: 2012-06-19
• Last updated: 2014-02-11

Locations

1 site across 1 country: United States