At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT) IN PATIENTS WITH HIGH RISK HEMOGLOBINOPATHIES LIKE SICKLE CELL DISEASE AND β-THALESSEMIA-MAJOR USING REDUCED INTENSITY CONDITIONING REGIMEN
In Brief
A Phase 2 clinical trial evaluating alemtuzumab (Campath IH), Fludarabine, and 5 other interventions for Sickle Cell Disease and Beta Thalassemia-Major. Completed, enrolled 29 participants across 1 site.
Detailed Summary
This study will evaluate the use of reduced intensity conditioning regimen in patients with high risk hemoglobinopathy Sickle Cell and B-Thalassemia Major in combination with standard immunosuppressive medications, followed by a routine stem cell transplant in order to assess whether or not it is as effective as myeloablative high dose chemotherapy and transplant.
Study Details
Timeline
Interventions
Alemtuzumab (Campath IH) is given daily over first 4 days, Day -20 to Day -17
Fludarabine 35/m2 is given daily over 4 days on Day -7 to Day -4.
Melphalan 70mg/m2 is given daily over 2 days on Day -3 to Day -2.
Immunosuppressant to prevent graft vs host disease is given on Day -1 prior to stem cell infusion
Immunosuppressant to prevent graft vs host disease is given on Day -1.
Immunosuppressant to prevent graft vs host disease is given Day -1 prior to stem cell infusion
Human Leukocyte Antigen (HLA) matched or mismatched; related or unrelated hematopoietic stem cells to be transplanted on Day 0.