Clinical Trial: Single or Double Donor Umbilical Cord Blood Transplant in Treating Patients With High-Risk Hematologic Malignancies

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Hematopoietic Stem Cell Transplantation Using Alternate Donor Umbilical Cord Blood Options

Brief Summary: This study will determine the safety and applicability of experimental forms of umbilical cord blood (UCB) transplantation for patients with high risk hematologic malignancies who might benefit from a hematopoietic stem cell transplant (HSCT) but who do not have a standard donor option (no available HLA-matched related donor (MRD), HLA-matched unrelated donor (MUD)), or single UCB unit with adequate cell number and HLA-match).

Detailed Summary:
Sponsor: University of Medicine and Dentistry of New Jersey

Current Primary Outcome:

  • Engraftment of white blood cells (WBC) (absolute neutrophil count > 500/mm^3) [ Time Frame: 3 years ]
  • Non-relapse mortality [ Time Frame: 40 months ]


Original Primary Outcome:

  • Engraftment of white blood cells (WBC) (absolute neutrophil count > 500/mm^3) [ Time Frame: By day 42 ]
  • Non-relapse mortality [ Time Frame: At day 100 ]
    Graded by a numerical score according to the National Cancer Institute (NCI)'s Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.


Current Secondary Outcome:

  • Platelet engraftment rate (non-transfusion dependent) [ Time Frame: At 100 days ]
  • Transplant related mortality [ Time Frame: At 1 year ]
  • Rates of infection requiring hospitalization or prolongation of hospitalization [ Time Frame: Up to 2 years ]
  • Incidence of steroid-refractory acute GVHD [ Time Frame: at 100 days ]
    GVHD will be staged per standard guidelines of the American Society for Blood and Bone Marrow Transplantation.
  • Incidence of extensive chronic GVHD [ Time Frame: up to 2 years ]
    GVHD will be staged per standard guidelines of the American Society for Blood and Bone Marrow Transplantation.
  • Total time on immunosuppressive therapy [ Time Frame: Up to 2 years ]
  • Time to CD4 count > 200/mm^3 [ Time Frame: Up to 2 years ]


Original Secondary Outcome: Same as current

Information By: Rutgers, The State University of New Jersey

Dates:
Date Received: July 20, 2012
Date Started: January 2014
Date Completion: January 2017
Last Updated: July 13, 2016
Last Verified: July 2016