Steroid-refractory aGvHD Subsequent to Allogeneic Hematopoietic Cell Transplantation Clinical Trial
Official title:
A Phase II Study of Neihulizumab vs "Conventional Treatment" to Treat Steroid-refractory Acute Graft-vs-host Disease (Sr-aGvHD) in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation
This study is to assess the efficacy of Neihulizumab versus "conventional therapy" and to evaluate safety, pharmacokinetics and immunogenicity in treating steroid-refractory acute Graft-vs-Host Disease
This current Phase II trial is a randomized, open label, controlled, multiple dose,
multi-centre study to study the clinical efficacy and safety of Neihulizumab vs
"Conventional Treatment" to treat steroid-refractory acute graft-vs-host disease (sr-aGvHD)
in patients undergoing allogeneic hematopoietic cell transplantation.
This study will enroll a minimum of 90 patients, approximately 60 in Neihulizumab treatment
arm and 30 in Conventional treatment control arm.
The primary objectives is to evaluate the efficacy of Neihulizumab treatment in patients
with steroid-refractory acute GvHD compared to "conventional treatment." The secondary
objectives are to investigate safety, pharmacokinetics, and immunogenicity of Neihulizumab
administration in subjects with steroid-refractory acute GvHD.
For safety evaluation, the parameters to be assessed are adverse events (AEs),
discontinuation of therapy due to AEs, safety laboratory analysis, ECG, vital signs,
physical examination, and immunogenicity.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment