RecruitMe Clinical Trial

Phase I Study of Itacitinib in Combination with Tocilizumab for the Treatment of Steroid Refractory Acute Graft versus Host Disease
Study of Itacitinib and Tocilizumab for the Treatment of Steroid Refractory Acute Graft versus Host Disease in Stem Cell Transplant
Sponsor:Columbia University
Enrolling:Male and Female Patients
Minimum Age:18 years old
IRB Number:AAAR8757
U.S. Government ID:NCT04070781
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information:

Graft versus host disease (GVHD) is a common complication after allogeneic stem cell transplant. It happens when the immune system of the donor is attacking the organs, and usually causes a skin rash, diarrhea, nausea and vomiting, and liver abnormalities. While it is often treated with steroids, some patients are considered steroid-refractory, which means the steroids are not working. This study is testing the combination of two medications, itacitinib and tocilizumab, that have shown some promise in steroid-refractory GVHD. The main purpose of this study is to find out whether the two study drugs are safe in combination because this combination has never been tested before. We will also look at whether the combination works well and has promise to be studied further. We chose this combination because each drug has shown promise in treating patients with steroid-refractory GVHD. After we check the safety of the combination, then the second part of the study will check the efficacy of the combination.

Do You Qualify?
Are you 18 years of age or older?YesNo
Have you had an allogeneic hematopoietic stem cell transplant?YesNo
Do you have steroid refractory acute graft versus host disease?YesNo
Are you able to swallow oral medication?YesNo
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Who Can I Contact?
For more information, please contact:
Research Nurse Navigator
Email: cancerclinicaltrials@cumc.columbia.edu
Phone: 212-342-5162