At a glance
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Reduced Intensity Conditioning for Haploidentical Bone Marrow Transplantation in Patients With Symptomatic Sickle Cell Disease. (BMTCTN1507)
In Brief
A Phase 2 clinical trial evaluating Haploidentical Bone Marrow Transplantation, Hydroxyurea, and 6 other interventions for Sickle Cell Disease. Completed, enrolled 95 participants across 32 sites.
Detailed Summary
This is a Phase II, single arm, multi-center trial, designed to estimate the efficacy and toxicity of haploidentical bone marrow transplantation (BMT) in patients with sickle cell disease (SCD). Based on their age and entry criteria patients are stratified into two groups: (1) children with severe SCD; and (2) adults with severe SCD.
Study Details
Timeline
Interventions
Eligible patients with a first degree Human Leukocyte Antigen (HLA)- haploidentical donor will undergo Haploidentical bone marrow transplantation at Day 0 with non T-cell depleted bone marrow. For Graft-vs-Host Disease (GVHD) prophylaxis, patients will be given sirolimus and mycophenolate mofetil beginning on Day +5.
HU will be given daily at 30mg/kg from Day -70 through Day -10.
Rabbit-ATG (rATG) will be given at 0.5mg/kg on Day -9, and at 2.0mg/kg on Day -8 and Day -7.
Thiotepa will be given at 10mg/kg on Day -7
Fludarabine will be given at 30mg/m2 from Day -6 to Day -2
Cyclophosphamide will be given at 14.5mg/kg on Day -6 and Day -5, and at 50 mg/kg on Days +3 and +4.
Total Body Irradiation will be given at 200cGy on Day -1
Mesna will be given at 40mg/kg on Days +3 and +4