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Study Status: Withdrawn
Recruit Status: Withdrawn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