University of Illinois at Chicago
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.
Patient Eligibility: 1. Patients with sickle cell disease are eligible if they have any of the following complications: 1.1 Stroke or central nervous system event lasting longer than 24 hours 1.2 Frequent vaso-occlusive pain episodes, defined as ≥ 3 per year requiring emergency room, acute care center, hospital admissions, or home bedrest leading to absence from work or school. 1.3 Recurrent episodes of priapism, defined as ≥ 2 per year requiring emergency room visits 1.4 Acute chest syndrome with recurrent hospitalizations, defined as ≥ 2 lifetime events 1.5 Red-cell alloimmunization (≥…
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
Arctuva estimate
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