Sickle Cell Disease Clinical Trial
Official title:
MT2014-10C: Allogeneic Hematopoietic Stem Cell Transplant for Patients With High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders
This is a study to collect the outcomes of stem cell transplantation for patients with hematologic diseases other than cancer.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | August 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota Medical Center, Fairview | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Masonic Cancer Center, University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of graft failure | 42 days | ||
Secondary | overall survival | 6 months, 1 and 2 years | ||
Secondary | disease free survival | patient no longer needing red blood cell transfusion and/or a hemoglobin S level at that of the donor ( sickle cell disease only) | 6 months, 1 and 2 years |
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