Clinical Trial: Immune Disorder HSCT Protocol
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Study of Hematopoietic Stem Cell Transplantation (HSCT) in Immune Function Disorders Using a Reduced Intensity Preparatory Regime
Brief Summary: This study hypothesizes that a reduced intensity immunosuppressive preparative regimen will establish engraftment of donor hematopoietic cells with acceptable early and delayed toxicity in patients with immune function disorders. A regimen that maximizes host immune suppression is expected to reduce graft rejection and optimize donor cell engraftment.
Detailed Summary:
Sponsor: Washington University School of Medicine
Current Primary Outcome: Number of participants with donor engraftment [ Time Frame: 1 year post transplant ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Major Transplant Related Toxicities [ Time Frame: 1 years post transplant ]
- Time to neutrophil recovery [ Time Frame: within 100 days post transplant ]
- Number of patient with acute GVHD [ Time Frame: 180 days post transplant ]
- Number of participants with infectious complications [ Time Frame: 2 years post transplant ]
- Time to immune reconstitution [ Time Frame: 2 years post transplant ]
- Overall survival [ Time Frame: 2 years post transplant ]
- Time to platelet recovery [ Time Frame: within 100 days post transplant ]
- Number of patients with chronic GVHD [ Time Frame: 2 years post transplant ]
- Disease free survival [ Time Frame: 2 years post transplant ]
Original Secondary Outcome: Same as current
Information By: Washington University School of Medicine
Dates:
Date Received: March 19, 2013
Date Started: March 2013
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016
