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An Open-Label, Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant

Clinical Trial Details

This a treatment program called an Expanded Access Program sponsored by Incyte Corporation to make the investigational drug Ruxolitinib available to patients with acute or chronic graft-versus-host disease (GVHD) in the United States, who are not eligible or able to participate in clinical trials conducted by Incyte Corporation. 
    
Additionally, this Program will collect data regarding the safety of ruxolitinib in people who have GVHD after undergoing allogeneic hematopoietic stem cell transplantation (allo-HCST). 
    
The study drug, Ruxolitinib is an investigational drug that is being studied by the Sponsor for use in the treatment of GVHD. Ruxolitinib will be provided to you as 5 mg tablets to be taken orally one to two times daily. 
    
You will participate in this Program for as long as you benefit from ruxolitinib. The duration of your participation in this Program will be based on standard of care as determined by the program doctor.

Key Eligibility: 

- Male or female, 18 years of age or older 
- Have undergone an allo-HSCT from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies 
- Clinically suspected all grades acute or chronic GVHD 
- Detailed eligibility will be reviewed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Ashlee N. Torres, RN
(212) 746-7117
ant9105@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1712018828

ClinicalTrials.gov:

NCT03147742

Sponsor:

 Jakafi EAP    

Status

Open to Enrollment

Age Group

Adult

Sponsor