A Phase 2 Study of TL-895 in People With Indolent Systemic Mastocytosis

Full Title

A Phase 2 Multicenter Study of TL-895 in Subjects with Myelofibrosis, Indolent Systemic Mastocytosis, Monoclonal Mast Cell Activation Syndrome, or Non-Monoclonal Mast Cell Activation Syndrome

Purpose

Researchers are assessing the drug TL-895 to treat indolent systemic mastocytosis (ISM). ISM is a long-lasting condition where blood cells called mast cells build up in the body. They cause symptoms such as itching, stomach pain, and tiredness.

TL-895 blocks the action of an enzyme called Bruton’s tyrosine kinase (BTK). Tyrosine kinases are involved in many cell functions, including signaling, growth, and division. The activation of BTK in mast cells may trigger ISM symptoms. TL-895 is taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

• Have a confirmed diagnosis of ISM. Patients with mast cell activation syndrome (MCAS) are not able to enroll at this institution.
• Have ISM causing moderate to severe symptoms.
• Have completed prior medical treatment for ISM at least 4 weeks before taking TL-895.
• Be able to walk and do routine activities for more than half the time you are awake.
• Be age 18 or older.

Contact

For more information about this study or to see if you can join, please call Dr. Brian Chernak’s office at 646-608-4366.