Purpose of this Study
We are doing this study to find out if an experimental drug called TL-895 (the study drug) is a safe and effective option for people with indolent systemic mastocytosis.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with indolent systemic mastocytosis</li>
<li>Have moderate-to-severe symptoms at the time of joining the study</li>
<li>Have had no prior treatment with any BTK or BMX inhibitor</li></ul>
For more information, please contact the study team at <a href= "mailto: terri.lucas@duke.edu">terri.lucas@duke.edu</a> or 919-681-6580.
<li>Are diagnosed with indolent systemic mastocytosis</li>
<li>Have moderate-to-severe symptoms at the time of joining the study</li>
<li>Have had no prior treatment with any BTK or BMX inhibitor</li></ul>
For more information, please contact the study team at <a href= "mailto: terri.lucas@duke.edu">terri.lucas@duke.edu</a> or 919-681-6580.
What is Involved?
This study is divided into 2 parts: Part A and Part B.
If you choose to join this study and are in Part A, you will get a random assignment (fair, equal chance) to 1 of 5 groups:<ul>
<li>Group 1 will take 50 mg of the study drug twice per day</li>
<li>Group 2 will take 75 mg of the study drug twice per day</li>
<li>Group 3 will take 100 mg of the study drug twice per day</li>
<li>Group 4 will take 150 mg of the study drug twice per day</li>
<li>Group 5 will take a placebo (inactive substance with no drug in it) twice per day</li></ul>
The study drug is a pill that you take by mouth. You will take the study drug or placebo for as long as you and the study doctor decide.
If you choose to join this study and are in Part B, you will take the study drug twice per day at whatever dose level was judged to be the best from Part A. You will take the study drug for as long as you and the study doctor decide.
Whether you participate in Part A or Part B will depend on when you join the study.
If you choose to join this study and are in Part A, you will get a random assignment (fair, equal chance) to 1 of 5 groups:<ul>
<li>Group 1 will take 50 mg of the study drug twice per day</li>
<li>Group 2 will take 75 mg of the study drug twice per day</li>
<li>Group 3 will take 100 mg of the study drug twice per day</li>
<li>Group 4 will take 150 mg of the study drug twice per day</li>
<li>Group 5 will take a placebo (inactive substance with no drug in it) twice per day</li></ul>
The study drug is a pill that you take by mouth. You will take the study drug or placebo for as long as you and the study doctor decide.
If you choose to join this study and are in Part B, you will take the study drug twice per day at whatever dose level was judged to be the best from Part A. You will take the study drug for as long as you and the study doctor decide.
Whether you participate in Part A or Part B will depend on when you join the study.
Study Details
Full Title
A Phase 2 Multicenter Study of TL-895 in Subjects with Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis, Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis, or Indolent Systemic Mastocytosis
Principal Investigator
Lindsay
Rein
Protocol Number
PRO00115016
NCT ID
NCT04655118
Phase
II
Enrollment Status
Open to Enrollment