UPCC 02419: An Open-label Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285) A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor in Patients with Advanced Systemic Mastocytosis
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- STATUS
- Recruiting
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- participants needed
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Summary
This research study is an open-label study designed to learn about the safety and effectiveness of an experimental drug called avapritinib (also known as BLU-285) when given to individuals who have been diagnosed with ASM, SM-AHN, or MCL. Experimental means that it is not yet known if this drug helps patients and is not available for sale. Open label means that you and your study doctor know you will receive avapritinib during the study. ASM, SM-AHN, or MCL (referred to as SM going forward) are disorders where abnormal mast cells accumulate in many organs and in bone marrow and cause abnormal organ function. Mast cells are a type of white blood cell that is part of the immune system. When increased in number or abnormal in function they release their contents resulting in allergic reactions and other related symptoms, which are also associated with mastocytosis.
Details
| Condition | Advanced Systemic Mastocytosis |
|---|---|
| Age | 99years or below |
| Clinical Study Identifier | 03580655 |
| Last Modified on | 19 February 2024 |
Eligibility
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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