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A Study Evaluating the Efficacy and Safety of Neihulizumab vs "Conventional Treatment" to Treat Sr-aGvHD

NCT02694770 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-04-25

No results posted yet for this study

Summary

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

Conditions

  • Steroid-refractory aGvHD Subsequent to Allogeneic Hematopoietic Cell Transplantation

Interventions

BIOLOGICAL

Neihulizumab Treatment

Monoclonal antibody

BIOLOGICAL

Conventional Treatment

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.

Sponsors & Collaborators

  • AbGenomics B.V Taiwan Branch

    lead INDUSTRY

Principal Investigators

  • Shih-Yao Lin, MD, PhD · AbGenomics B.V.

  • Paul Martin (Lead), MD · Fred Hutchinson Cancer Center

  • Marco Mielcarek (Co-Lead), MD · Fred Hutchinson Cancer Center

  • Amin Alousi (Co-Lead), MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-09-30
Completion
2018-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02694770 on ClinicalTrials.gov