CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
Belimumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03207958
NCT03207958Phase 1Completed

A Pilot Study of Belimumab (Benlysta) for Prevention of Chronic Graft-versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation

Washington University School of Medicine·interventional·Posted Jul 5, 2017·Updated Apr 20, 2026

In Brief

A Phase 1 clinical trial evaluating Belimumab for Graft Vs Host Disease and Graft-versus-host-disease. Completed, enrolled 10 participants across 1 site.

Detailed Summary

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 prophylaxis of chronic GvHD. The investigators propose a pilot and feasibility study to assess the safety and tolerability, as well as preliminary efficacy, of belimumab as prophylaxis of chronic GvHD following allogeneic hematopoietic cell transplantation (alloHCT). The investigators' central hypothesis is that belimumab will be well tolerated and have a favorable effect on incidence and severity of chronic GvHD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJul 5, 2017
Enrollment StartMay 16, 2018
Primary CompletionJun 4, 2022
Study CompletionFeb 9, 2024
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 9.0 years ago

Interventions

Belimumabdrug

-Given over 1 hour