Clinical Trial: Allo HSCT Using RIC for Hematological Diseases

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

Official Title: Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) for the Treatment of Hematological Diseases [MT2015-32]

Brief Summary: This is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related or unrelated donor stem cell infusion. The primary objective is to evaluate rates of acute graft-versus-host disease (GVHD) grades II-IV and chronic GVHD with an updated GVHD prophylaxis of tacrolimus and mycophenolate mofetil (MMF) with a non-myeloablative preparative regimen in persons with hematologic malignancies.

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

Current Primary Outcome: Evaluate rates of acute graft-versus-host disease (GVHD) II-IV [ Time Frame: Day 100 post transplant ]

Percent of subjects with grade II-IV acute GVHD


Original Primary Outcome: Percent of subjects with grade II-IV acute GVHD [ Time Frame: Day 100 post transplant ]

Current Secondary Outcome:

  • Evaluate rates of chronic GVHD [ Time Frame: 1 year post transplant ]
    Percent of subjects with chronic GVHD
  • Evaluate neutrophil engraftment without ATG (in siblings) [ Time Frame: Day 42 post transplant ]
    Percent of subjects with neutrophil engraftment without ATG (in siblings)
  • Evaluate neutrophil engraftment with ATG (in unrelated donors) [ Time Frame: Day 42 post transplant ]
    Percent of subjects with neutrophil engraftment with ATG (in unrelated donors)
  • Evaluate neutrophil engraftment without ATG (in unrelated donors) [ Time Frame: Day 42 post transplant ]
    Percent of subjects with neutrophil engraftment without ATG (in unrelated donors)
  • Evaluate relapse without ATG (in siblings) - 1 year [ Time Frame: 1 year post transplant ]
    Percent of subjects who relapsed without ATG (in siblings)
  • Evaluate relapse without ATG (in siblings) - 2 years [ Time Frame: 2 years post transplant ]
    Percent of subjects who relapsed without ATG (in siblings)
  • Evaluate relapse with ATG (in unrelated donors) - 1 year [ Time Frame: 1 year post transplant ]
    Percent of subjects who relapsed with ATG (in unrelated donors)
  • Evaluate relapse with ATG (in unrelated donors) - 2 years [ Time Frame: 2 years post transplant ]
    Percent of subjects who relapsed with ATG (in unrelated donors)
  • Evaluate relapse without ATG (in unrelated donors) - 1 year [ Time Frame: 1 year post transplant ]
    Percent of subjects who relapsed without ATG (in unrelated donors)
  • Evaluate relapse without ATG (in unrelated donors) - 2 years [ Time Frame: 2 years post transplant ]
    Percent of subjects who relapsed without ATG (in unrelated donors)
  • Overall survival [ Time Frame: Day 100 post transplant ]
    Percent of surviving subjects
  • Overall survival [ Time Frame: 1 year post transplant ]
    Percent of surviving subjects
  • Overall survival [ Time Frame: 3 years post transplant ]
    Percent of surviving subjects
  • Transplant related mortality (TRM) [ Time Frame: Day 100 post transplant ]
    Percent of subjects with TRM
  • Transplant related mortality (TRM) [ Time Frame: 1 year post transplant ]
    Percent of subjects with TRM


Original Secondary Outcome:

  • Percent of subjects with chronic GVHD [ Time Frame: 1 year post transplant ]
  • Percent of subjects with neutrophil engraftment without ATG (in siblings) [ Time Frame: Day 42 post transplant ]
  • Percent of subjects with neutrophil engraftment with ATG (in unrelated donors) [ Time Frame: Day 42 post transplant ]
  • Percent of subjects with neutrophil engraftment without ATG (in unrelated donors) [ Time Frame: Day 42 post transplant ]
  • Percent of subjects who relapsed without ATG (in siblings) [ Time Frame: 1 year post transplant ]
  • Percent of subjects who relapsed without ATG (in siblings) [ Time Frame: 2 years post transplant ]
  • Percent of subjects who relapsed with ATG (in unrelated donors) [ Time Frame: 1 year post transplant ]
  • Percent of subjects who relapsed with ATG (in unrelated donors) [ Time Frame: 2 years post transplant ]
  • Percent of subjects who relapsed without ATG (in unrelated donors) [ Time Frame: 1 year post transplant ]
  • Percent of subjects who relapsed without ATG (in unrelated donors) [ Time Frame: 2 years post transplant ]
  • Overall survival [ Time Frame: Day 100 post transplant ]
  • Overall survival [ Time Frame: 1 year post transplant ]
  • Overall survival [ Time Frame: 3 years post transplant ]
  • Transplant related mortality [ Time Frame: Day 100 post transplant ]
  • Transplant related mortality [ Time Frame: 1 year post transplant ]


Information By: Masonic Cancer Center, University of Minnesota

Dates:
Date Received: January 19, 2016
Date Started: March 9, 2017
Date Completion: March 2023
Last Updated: March 9, 2017
Last Verified: March 2017