Given the role of B cells in the pathophysiology of chronic graft versus host disease (GvHD), the association between elevated BAFF levels post-transplant in abnormal B-cell homeostasis and chronic GvHD, and the efficacy of belimumab in the inhibition of soluble human B lymphocyte stimulator protein (BAFF) signaling, these proof-of-principle findings support the rational for use of belimumab as treatment of chronic GvHD.The investigators propose a pilot and feasibility study to assess the safety and tolerability, as well as preliminary efficacy, of belimumab a treatment of cGvHD following allogeneic hematopoietic cell transplantation (alloHCT). The investigators' central hypothesis is that belimumab will be well tolerated and have a favorable effect on chronic GvHD,and we explored therapeutic dosage of belimumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Belimumab will be administered intravenously every 2 weeks for 3 cycles and then every 4 weeks for a total of 5 cycles
Department of Hematology, Nanfang Hospital, Southern Medical University,
Guanzhou, China
Overall response rate of chronic GvHD after belimumab treatment
cGVHD grade according NIH
Time frame: approximately 6 months
Duration of response rate of chronic GvHD after belimumab treatment
Duration of ORR chronic GvHD after belimumab treatment
Time frame: 12 months
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