Study of HLA-Haploidentical Stem Cell Transplantation to Treat Clinically Aggressive Sickle Cell Disease
A Phase II Study of HLA-Haploidentical Stem Cell Transplantation to Treat Clinically Aggressive Sickle Cell Disease
University of Illinois at Chicago
50 participants
Mar 20, 2017
INTERVENTIONAL
Conditions
Summary
The study is a Phase II clinical trial. Patients will receive intensity modulated total body irradiation (TBI) at a dose of 3 Gy with standard fludarabine/ i.v. cyclophosphamide conditioning prior to human leukocyte antigen (HLA)-haploidentical hematopoietic stem cell transplant (HSCT). The primary objective of the study is to determine the engraftment at Day +60 following HLA-haploidentical hematopoietic stem cell transplant protocol using immunosuppressive agents and low-dose total body irradiation (TBI) for conditioning and post-transplant cyclophosphamide in patients with sickle cell disease.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
0.5 mg/kg IV on day -9, and 2 mg/kg on days -8 and day -7
30 mg/m2 IVPB daily for day -6 (6 days before stem cell infusion) through day -2
14.5 mg/kg IV on days -6 and -5 and 50 mg/kg/d on days +3 and +4
3 Gy on day -1
Stem cell product infused according to BMT unit policy on day 0.
loading dose of 15 mg followed by 5 mg per day on day +5
1 g every 8 h (until day 35) will be started on day 5
Locations(1)
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NCT03121001