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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Monoclonal antibody
2nd line therapy for aGvHD at the discretion of attending physician, including but not limited to biologics such as ATG, TNF-alpha inhibitors, pentostatin, sirolimus, mycophenolate mofetil and extracorporeal photopheresis.
MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Overall response rate (Complete Response+Partial Response)
Time frame: Day 28 after the initiation of sr-aGvHD treatment
Overall response rate (Complete Response+Partial Response)
Time frame: Day 56 after the initiation of sr-aGvHD treatment
Complete Response+Very Good Partial Response
Time frame: Day 28 and Day 56 after the initiation of sr-aGvHD treatment
Overall survival
Time frame: Day 180 after the initiation of sr-aGvHD treatment
Cumulative steroid dose
Time frame: Day 28 after the initiation of sr-aGvHD treatment
Cumulative incidence of chronic GvHD
Time frame: Day 180 after the initiation of sr-aGvHD treatment
Cumulative incidence of primary disease relapse
Time frame: Day 180 after the initiation of sr-aGvHD treatment
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