Allogeneic Stem Cell Transplantation Clinical Trial
— BortezomibOfficial title:
Use of Bortezomib to Treat Refractory Autoimmune Cytopenia(s) in Allogeneic Stem Cell Transplantation
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.
Status | Completed |
Enrollment | 4 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Months to 29 Years |
Eligibility |
Inclusion Criteria: - All patients, having undergone allogeneic stem cell transplantation at our center. - Should have failed at least 2 standard treatments for autoimmune cytopenias. Standard treatments include corticosteroids, rituximab, IVIG, plasmapheresis, withdrawal of cyclosporine, cyclophosphamide and MMF. Definition of "failed" treatment will be no response of cytopenia after 2 weeks of continued treatment OR requirement of daily GCSF at 10 mcgs/kg/day for autoimmune neutropenia despite 2 weeks of treatment, transfusions of packed red blood cells or platelets 3 times weekly for 2weeks despite continued treatment OR 5days/week plasmapheresis for 2 weeks and inability to wean the duration. - Definition of autoimmune hemolytic anemia- development of anemia, where there is a hemoglobin drop of >2 g/dL/48 hours or an absolute value of hemoglobin < 8 g/dL, and evidence of hemolysis by positive direct Coombs test with compatible peripheral blood cell morphology, reticulocyte count and bilirubin level. - Definition of autoimmune neutropenia - absolute neutrophil counts < 500 for 2 weeks and presence of anti-neutrophil antibodies. - Definition of autoimmune thrombocytopenia- Platelet counts < 20,000 cells/uL for 2 weeks and presence of anti-platelet antibodies. Exclusion Criteria: - Ongoing life threatening infections - Documented anaphylaxis to bortezomib - Failed engraftment - Relapse of primary malignancy - =6/8 matched or haploidentical transplants |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Response | For Autoimmune Hemolytic Anemia- At least 3 of 5 criteria should be met. Stabilization of hemoglobin without transfusions by 2 weeks Conversion of DAT from + to - by 6 weeks Normalization of serum haptoglobin levels by 6 weeks Normalization of indirect bilirubin levels by 6 weeks Reduction in the frequency of transfusions by 50% by 4 weeks For Autoimmune Neutropenia- At least 2 of 3 criteria should be met. Stabilization of absolute neutrophil count by 2 weeks Undetectable antineutrophil antibodies by 6 weeks Reduction in GCSF dose by 50% by 6 weeks For Autoimmune Thrombocytopenia- At least 2 of 3 criteria should be met. Stabilization of platelet count without platelet transfusions by 2 weeks Undetectable antiplatelet antibodies by 6 weeks Reduction in the frequency of platelet transfusions by 50% from pre-bortezomib values by 6 weeks |
6 weeks | No |
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