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Recruiting Phase 1, Phase 2 NCT03128996

Reduced Intensity Conditioning and Familial HLA-Mismatched BMT for Non-Malignant Disorders

Trial Parameters

Condition Severe Sickle Cell Disease
Sponsor Washington University School of Medicine
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 29
Sex ALL
Min Age 1 Day
Max Age 21 Years
Start Date 2017-03-20
Completion 2028-04
Interventions
RIC regimenGVHD prophylaxis regimen

Brief Summary

This study is designed to estimate the efficacy and toxicity of familial HLA mismatched bone marrow transplants in patients with non-malignant disease who are less than 21 years of age and could benefit from the procedure.

Eligibility Criteria

Inclusion Criteria: * Nonmalignant disorder requiring bone marrow transplant including bone marrow failure syndromes, metabolic disorders, immunologic disorders, or hemoglobinopathy * For patients with sickle cell disease, must have one of the following severe manifestations: 1. Overt or silent stroke or persistently elevated transcranial doppler velocities despite transfusion therapy 2. Recurrent acute chest syndrome with significant respiratory compromise each time 3. Sickle nephropathy 4. Recurrent admissions for vaso-occlusive episodes resulting in prolonged opioid use and poor quality of life with interrupted school attendance activity 5. Red cell alloimmunization with the need for chronic transfusions 6. Recurrent osteonecrosis or multiple joint involvement from avascular necrosis * Patients with sickle cell disease must have hemoglobin S \< 30% within 30 days prior to beginning alemtuzumab * Age \</= 20.99 years at the time of enrollment * Performance score \>/= 50 * Left ventri

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