Clinical Trial: Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies

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

Official Title: Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies

Brief Summary: This is a standard of care treatment guideline for allogeneic hematopoetic stem cell transplant (HSCT) in patients with primary immune deficiencies.

Detailed Summary:

Based on diagnosis and clinical history, a determination of the most appropriate regimen will be made based on the following prep plans:

Arm A: Fully Myeloablative Preparative Regimen, Arm B: Reduced Toxicity Ablative Preparative Regimen, Arm C: Reduced Intensity Conditioning, Arm D: No Preparative Regimen


Sponsor: Masonic Cancer Center, University of Minnesota

Current Primary Outcome: Neutrophil Engraftment [ Time Frame: Day 42 ]

Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm3 (0.5 x 109/L) or greater.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of Graft Failure [ Time Frame: Day 100 ]
    Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.
  • Incidence of Chimerism [ Time Frame: Day 100, 6 Months, 1 Year ]
    a state in bone marrow transplantation in which bone marrow and host cells exist compatibly without signs of graft-versus-host rejection disease.
  • Incidence of Acute Graft-Versus-Host Disease [ Time Frame: Day 100 ]
    Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.
  • Incidence of Chronic Graft-Versus-Host Disease [ Time Frame: 6 Months and 1 Year ]
    Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.
  • Incidence of Transplant-Related Mortality [ Time Frame: 6 Months ]
    In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.
  • Disease-Free Survival [ Time Frame: 6 Months ]
    the length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.
  • Overall Survival [ Time Frame: 6 Months ]
    Overall survival will be defined as time from enrollment to date of death or censored at the date of last documented contact for patients still alive.


Original Secondary Outcome: Same as current

Information By: Masonic Cancer Center, University of Minnesota

Dates:
Date Received: July 25, 2012
Date Started: September 4, 2012
Date Completion: December 2020
Last Updated: February 17, 2017
Last Verified: February 2017