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


Description

This is a study to collect the outcomes of stem cell transplantation for patients with hematologic diseases other than cancer.

Trial 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

Study Info

Organization

Masonic Cancer Center, University of Minnesota


Primary Outcome

incidence of graft failure


Outcome Timeframe 42 days

NCTID NCT02179359

Phases NA

Primary Purpose TREATMENT

Start Date 2014-09-02

Completion Date 2025-01

Enrollment Target 25

Interventions

DRUG Reduced Toxicity Ablative Regimen

DRUG Reduced Intensity Preparative Regimen

DRUG Myeloablative Preparative Regimen

Locations Recruiting

University of Minnesota Medical Center, Fairview

United States, Minnesota, Minneapolis


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