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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Masonic Cancer Center, University of Minnesota

Current Primary Outcome: Survival at 1 year post-transplant [ Time Frame: 1 year ]

The number of patients that are still living 1 year after UCBT.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of neutrophil engraftment at day 42. [ Time Frame: 42 days ]
    Number of subjects with neutrophil engraftment at day 42 post UCBT.
  • Platelet engraftment at 1 year. [ Time Frame: 1 year ]
    Number of patients with platelet engraftment at 1 year post UCBT.
  • Pattern of chimerism after transplant. [ Time Frame: 1 year ]
    Pattern of chimerism after transplant. Chimerism will be plotted with box-plots and described over time.
  • Incidence of graft failure. [ Time Frame: 100 days ]
    Cumulative incidence of graft failure after UCBT.
  • Incidence of acute graft versus host disease at 100 days. [ Time Frame: 100 days ]
    Cumulative incidence will be used to estimate acute graft versus host disease 100 days after UCBT.
  • Incidence of chronic graft versus host disease at 1 year. [ Time Frame: 1 year ]
    Cumulative incidence will be used to estimate chronic GVHD at 1 year post UCBT.
  • Incidence of transplant related mortality at 6 months. [ Time Frame: 6 months ]
    Cumulative incidence will be used to estimate transplant related mortality at 6 months post UCBT.
  • Incidence of disease free survival [ Time Frame: 1, 2 years ]
    Kaplan-Meier curves will be used to estimate disease-free survival at 1 and 2 years post UCBT.
  • Incidence of overall survival. [ Time Frame: 1, 2 years ]
    Kaplan-Meier curves will be used to estimate overall survival at 1 and 2 years post UCBT.


Original Secondary Outcome:

  • Incidence of neutrophil engraftment at day 42. [ Time Frame: 42 days ]
    Number of subjects with neutrophil engraftment at day 42 post UCBT.
  • Platelet engraftment at 1 year. [ Time Frame: 1 year ]
    Number of patients with platelet engraftment at 1 year post UCBT.
  • Pattern of chimerism after transplant. [ Time Frame: 1 year ]
    Pattern of chimerism after transplant. Chimerism will be plotted with box-plots and described over time.
  • Incidence of graft failure. [ Time Frame: 42 days ]
    Cumulative incidence of graft failure after UCBT.
  • Incidence of acute graft versus host disease at 100 days. [ Time Frame: 100 days ]
    Cumulative incidence will be used to estimate acute graft versus host disease 100 days after UCBT.
  • Incidence of chronic graft versus host disease at 1 year. [ Time Frame: 1 year ]
    Cumulative incidence will be used to estimate chronic GVHD at 1 year post UCBT.
  • Incidence of transplant related mortality at 6 months. [ Time Frame: 6 months ]
    Cumulative incidence will be used to estimate transplant related mortality at 6 months post UCBT.
  • Incidence of disease free survival [ Time Frame: 2 years ]
    Kaplan-Meier curves will be used to estimate disease-free survival at 1 and 2 years post UCBT.
  • Incidence of overall survival. [ Time Frame: 2 years ]
    Kaplan-Meier curves will be used to estimate overall survival at 1 and 2 years post UCBT.


Information By: Masonic Cancer Center, University of Minnesota

Dates:
Date Received: October 10, 2013
Date Started: December 2016
Date Completion: October 2023
Last Updated: August 15, 2016
Last Verified: August 2016