Clinical Trial: UCB Transplant for Hematological Diseases Using a Non Myeloablative Prep

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Transplantation of Umbilical Cord Blood From Unrelated Donors in Patients With Hematological Diseases Using a Non-Myeloablative Preparative Regimen

Brief Summary: This is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen with modifications based on factors including diagnosis, disease status, and prior treatment. Single or double unit selected according to current University of Minnesota umbilical cord blood graft selection algorithm.

Detailed Summary:
Sponsor: Masonic Cancer Center, University of Minnesota

Current Primary Outcome: Probability of Acute Graft Versus Host Disease (GVHD) [ Time Frame: Day 100 ]

Original Primary Outcome: Probability of Acute GHVD [ Time Frame: Day 100 ]

Current Secondary Outcome:

• Incidence of Acute GVHD [ Time Frame: Day 100 ]
  Percentage of patients with grade III-IV acute GVHD.
• Transplant related mortality [ Time Frame: 6 months post transplant ]
• Chimerism [ Time Frame: Day 21 ]
  Percentage of subjects with donor chimerism.
• Chimerism [ Time Frame: Day 100 ]
  Percentage of subjects with donor chimerism.
• Chimerism [ Time Frame: Day 180 ]
  Percentage of subjects with donor chimerism.
• Chimerism [ Time Frame: 1 year post transplant ]
  Percentage of subjects with donor chimerism.
• Neutrophil Engraftment [ Time Frame: Day 42 ]
  Percentage of subjects with neutrophil engraftment.

Original Secondary Outcome: Same as current

Information By: Masonic Cancer Center, University of Minnesota

Dates:
Date Received: March 24, 2016
Date Started: May 15, 2017
Date Completion: December 2029
Last Updated: May 16, 2017
Last Verified: May 2017