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Bortezomib to Treat Significant Complication of HSCT — Bortezomib  

Allogeneic Stem Cell Transplantation Clinical Trial

Official title:
Use of Bortezomib to Treat Refractory Autoimmune Cytopenia(s) in Allogeneic Stem Cell Transplantation

Clinical Trial Summary

The purpose of this trial is to study the safety and effectiveness of a drug called Bortezomib for the treatment of low blood cell counts after bone marrow transplant.

Clinical Trial Description

The purpose of this research study is to study the safety and effectiveness of a drug called bortezomib for the treatment of autoimmune cytopenia(s) (low blood cell counts) after bone marrow transplant that are not responding to standard treatments. Autoimmune cytopenias are low blood counts due to antibodies or proteins produced against an individual's own blood cells. Having a low red blood cell count (anemia) can make a person feel tired and require blood transfusions frequently. A low platelet count (blood cells that help blood to clot) can make a person bleed or bruise easily. A low neutrophil (white blood cell) count can make a person have infections.

All of these things can be a serious complication after bone marrow transplant and can cause prolonged hospital stay. Bortezomib is being used in children with certain types of blood cancer, however, bortezomib has not been used in children with autoimmune cytopenia(s) and its use in this study is investigational. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Allogeneic Stem Cell Transplantation
  • Refractory Autoimmune Cytopenia(s)
Clinical Trial Details
NCT number NCT01929980
Study type Interventional
Source Children's Hospital Medical Center, Cincinnati
Contact
Status Completed
Phase Phase 2
Start date July 2012
Completion date May 2014
View Details
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