A Phase 2, Single-Arm, Open-Label Study of Itacitinib, for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
Sponsor: Incyte Corporation
Enrolling: Male and Female Patients
IRB Number: AAAS6996
U.S. Govt. ID: NCT04071366
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: Patients who will be receiving immune effector cell (IEC) therapy for the treatment of their cancer (leukemia) are being asked to participate in this study. IEC can produce a harmful side effect called Cytokine Release Syndrome (CRS). CRS involves a release of a large amount of proteins into the bloodstream. This may cause changes in blood pressure and heartbeat, flu-like symptoms (nausea, fever, and chills), and/or affect lung/liver/kidney function. It may also cause certain brain-related symptoms, such as dizziness, weakness, confusion, difficulty speaking, and/or decreased brain function (possible paralysis and/or coma). This study is being done to see if the study drug, itacitinib, is effective at preventing CRS. Itacitinib is an investigational drug that is being studied by Incyte Corporation for use in the treatment of CRS. Participants will receive the study drug in addition to their normal treatment.
This study is closed
Ran Reshef, MD
Do You Qualify?
Are you 18 years of age or older? Yes No
Will you be receiving Immune Effector Cell Therapy for the treatment of your cancer? Yes No
Would you be willing to make extra visits to the clinic for additional tests and procedures? Yes No
You may be eligible for this study

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