NCT01929980

Bortezomib to Treat Significant Complication of HSCT

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 4 Months – 29 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Allogeneic Stem Cell Transplantation
• Refractory Autoimmune Cytopenia(s)

Interventions

Type	Name	Description
DRUG	Bortezomib

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-08-28
• Last updated: 2016-10-24
• Results posted: 2016-10-24

Locations

1 site across 1 country: United States