At a glance
ClinicalIndex Comparison Record- ✓Sickle cell disease with one or more severe complications: acute chest syndrome requiring hospitalization, nonhemorrhagic stroke or CNS event >24 hours, recurrent vaso-occlusive pain or priapism, sickle neuropathy, bilateral proliferative retinopathy with major visual impairment, osteonecrosis of multiple joints, transfusion dependence, or vaso-occlusive crisis.
- ✓Thalassemia with one or more of: transfusion dependence, iron overload, or ≥2 alloantibodies against red cell antigens.
- ✕Pregnancy
- ✕Acute hepatitis
- ✕Cardiac ejection fraction <30%
- ✕Severe renal impairment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-Center Study Using Allogeneic Stem Cell Transplantation Following Reduced Intensity Chemotherapy in Patients With Hemoglobinopathies
In Brief
A Phase 2 clinical trial evaluating Busulfex, Fludarabine, and 2 other interventions for Hemoglobinopathies and 2 related conditions. Completed, enrolled 2 participants across 6 sites.
Detailed Summary
The purpose of this study is to determine if treatment with reduced-dose busulfex, fludarabine and alemtuzumab (CAMPATH) followed by sten cell infusion will allow for donor stem cells to grow in patients with hemoglobinopathies bone marrow and restore circulating blood counts. In addition the incidence and severity of side effects and of graft vs. host disease (GVHD) will be monitored.
Study Details
Timeline
Interventions
Given once daily for 4 days
Given intravenously once daily for 4 days
One day before fludarabine and busulfex are started, alemtuzumab will be given once daily for 5 days.
Performed three days after the end of chemotherapy