Phase I Rux+Fosta for Steroid Refractory cGvHD (Graft versus Host Disease)

Purpose of this Study

We are doing this study to find out if an investigational drug called fostamatinib (the study drug) is beneficial for cGvHD when it is used in combination with a standard of care drug, ruxolitinib. We want to know if the study drug can improve relief from cGvHD symptoms.

Who Can Participate?

Eligibility

Adults ages 18-80 who:
  • Are diagnosed with cGvHD
  • Are either dependent on steroids or non-responsive to steroids
  • Have received an allogeneic hematopoietic cell transplant (HCT)
For more information about who can join this study, please contact one of the study team members below: Chenyu Lin: chenyu.lin@duke.edu or 919-684-8964 Michelle Araque: michelle.araque@duke.edu or 919-660-0982

What is Involved?

Description

If you choose to join the study, you will:
  • Have a physical exam done and medical history taken
  • Have vital signs taken
  • Have blood draws
  • Have a pulmonary function (breathing) test
  • Fill out questionnaires
  • Take a combination of the study drug and ruxolitinib (pills that you take by mouth)

Study Details

Full Title

Phase I Trial of Ruxolitinib Plus Fostamatinib for the Treatment of Steroid Refractory Chronic Graft versus Host Disease

Principal Investigator

Chenyu
Lin

Protocol Number

PRO00113327

NCT ID

NCT06233110

Phase

I

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov