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MT2014-10C : Allogeneic Hematopoietic Stem Cell Transplant for Patients with High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders

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This is a treatment study for a allogeneic hematopoietic stem cell transplantation (HSCT) in patients with sickle cell disease (SCD), thalassemia, Diamond Blackfan Anemia (DBA) and other non-malignant hematologic disorders that are transfusion dependent or represent other potentially life-threatening cytopenias. The objective of this study is to confirm the findings of our previous allogeneic hematopoietic stem cell transplant trial for non-malignant hematologic disorders that are transfusion dependent or represent other potentially life-threatening cytopenias including: • incidence of graft failure • disease free survival (DFS) including red cell transfusion independence at 6 months, 1 and 2 years • overall survival at 6 months, 1 and 2 years

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Inclusion Criteria:
* Diagnosis of Sickle Cell Disease, Thalassemia, Diamond Blackfan Anemia or other non-malignant hematologic disorders for which a stem cell transplant is indicated * Acceptable stem cell source identified * Performance status of ≥ 70% (Karnofsky),or ≥ 70 (Lansky play score) * Creatinine \<2.0 mg/dl for adults or glomerular filtration rate \> 50 ml/min for children * Bilirubin, Aspartate Aminotransferase, Alkaline phosphatase \<5 times the upper limit of institutional normal * Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \> 40%
Exclusion Criteria:
* active, uncontrolled infection * pregnant or breastfeeding * HIV positive

Clinics and Surgery Center (CSC)

Holly Franceen - hfrancee@umn.edu
Ashish Gupta
NA
1407M52125
16421
See this study on ClinicalTrials.gov

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