A Phase II Study of Visilizumab for the Prevention of Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
This protocol is a two stage, controlled, phase II study, to assess safety and compare the
grade of acute graft-versus-host disease (GVHD) with visilizumab or thymoglobulin (ATG) in
combination with tacrolimus + methotrexate in patients at high risk of GVHD after transplant
from unrelated donors mismatched for 1-2 alleles of any type at HLA A, B, C and DRB1.
The study design includes two stages. The first stage of the trial will enroll 15 patients
on a single arm to be treated with "study treatment" (visilizumab, tacrolimus and
methotrexate) to assess for treatment safety and exclude intolerable GVHD. The second stage
of the trial includes a random control group of patients treated with the current "standard
treatment" (ATG, tacrolimus, and methotrexate) or "study treatment". The purpose of this
comparison is to determine if the "study treatment" visilizumab causes less severe side
effects and if it is more potent in reducing graft-versus-host disease symptoms than the
In addition, immunological studies will be conducted to test the pharmacokinetics,
immunogenicity, and pharmacodynamics of visilizumab or ATG administered for GVHD prophylaxis
after hematopoietic cell transplantation.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
To assess whether the grade of acute GVHD is decreased by visilizumab in combination with tacrolimus/methotrexate compared to standard treatment with thymoglobulin/tacrolimus/methotrexate after transplantation from unrelated mismatched donors.
Day of transplant up to one year
Lia Perez, MD
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center & Research Institute||Tampa, Florida 33612|