Status:
COMPLETED
(PROSPECTOR) Screening Study Evaluating the Prevalence of the KIT D816V Mutation in Patients With Systemic Mast Cell Activation
Lead Sponsor:
Blueprint Medicines Corporation
Conditions:
Systemic Mast Cell Activation
KIT D816V Mutation
Eligibility:
All Genders
18+ years
Brief Summary
This is a multi-center screening study with the primary objective to determine the prevalence of KIT D816V mutation in peripheral blood in patients with evidence of systemic mast cell activation (MCA)...
Eligibility Criteria
Inclusion
- Presenting with at least one of the three criteria below as evidence of systemic mast cell activation:
- Involvement of 2 or more organ systems, characterized by skin (pruritus, urticaria, flushing and angioedema), cardiovascular (tachycardia, syncope, and hypotension), gastrointestinal (diarrhea, nausea, vomiting, and gastrointestinal cramping) or respiratory/naso-ocular (wheezing, conjunctival injection, and nasal stuffiness) AND serum basal tryptase levels ≥8 ng/ml. One of the organ systems must be the cardiovascular system.
- Severe anaphylaxis (Ring and Messmer grading ≥II) due to Hymenoptera sting, regardless of serum basal tryptase levels.
- Severe anaphylaxis (Ring and Messmer grading ≥II), with cardiovascular involvement and documented event-related tryptase elevation fitting the formula 20% of baseline plus 2 ng/ml evaluated in at least 1 event.
Exclusion
- Patient previously diagnosed with any of the following WHO systemic mastocytosis (SM) sub-classifications: mastocytosis in the skin, indolent SM, smoldering SM, SM with associated hematological neoplasm, aggressive SM, mast cell leukemia, mast cell sarcoma
Key Trial Info
Start Date :
June 29 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
379 Patients enrolled
Trial Details
Trial ID
NCT04811365
Start Date
June 29 2021
End Date
March 31 2023
Last Update
April 6 2023
Active Locations (23)
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1
Clinical Research Center of Alabama
Birmingham, Alabama, United States, 35209
2
Scripps Clinic Carmel Valley
San Diego, California, United States, 92130
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
4
University of Michigan
Ann Arbor, Michigan, United States, 48105