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:<ul>
<li>Are diagnosed with cGvHD</li>
<li>Are either dependent on steroids or non-responsive to steroids</li>
<li>Have received an allogeneic hematopoietic cell transplant (HCT)</li></ul>
For more information about who can join this study, please contact one of the study team members below:
Chenyu Lin: <a href= "mailto: chenyu.lin@duke.edu">chenyu.lin@duke.edu</a> or 919-684-8964
Michelle Araque: <a href= "mailto: michelle.araque@duke.edu">michelle.araque@duke.edu</a> or 919-660-0982
<li>Are diagnosed with cGvHD</li>
<li>Are either dependent on steroids or non-responsive to steroids</li>
<li>Have received an allogeneic hematopoietic cell transplant (HCT)</li></ul>
For more information about who can join this study, please contact one of the study team members below:
Chenyu Lin: <a href= "mailto: chenyu.lin@duke.edu">chenyu.lin@duke.edu</a> or 919-684-8964
Michelle Araque: <a href= "mailto: michelle.araque@duke.edu">michelle.araque@duke.edu</a> or 919-660-0982
What is Involved?
If you choose to join the study, you will:<ul>
<li>Have a physical exam done and medical history taken</li>
<li>Have vital signs taken</li>
<li>Have blood draws</li>
<li>Have a pulmonary function (breathing) test</li>
<li>Fill out questionnaires</li>
<li>Take a combination of the study drug and ruxolitinib (pills that you take by mouth)</li></ul>
<li>Have a physical exam done and medical history taken</li>
<li>Have vital signs taken</li>
<li>Have blood draws</li>
<li>Have a pulmonary function (breathing) test</li>
<li>Fill out questionnaires</li>
<li>Take a combination of the study drug and ruxolitinib (pills that you take by mouth)</li></ul>
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