(PROSPECTOR) Screening Study Evaluating the Prevalence of the KIT D816V Mutation in Patients With Systemic Mast Cell Activation

  • STATUS
    Recruiting
  • End date
    Aug 5, 2022
  • participants needed
    400
  • sponsor
    Blueprint Medicines Corporation
Updated on 5 August 2021
Investigator
Blueprint Medicines
Primary Contact
Brigham and Women's Hospital (4.5 mi away) Contact
+1 other location

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).

Details
Condition Systemic Mast Cell Activation, KIT D816V Mutation
Treatment Screening
Clinical Study IdentifierNCT04811365
SponsorBlueprint Medicines Corporation
Last Modified on5 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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, recurrent anaphylaxis (Ring and Messmer grading II) due to Hymenoptera sting, regardless of serum basal tryptase levels
Severe, recurrent 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 Criteria

Patient previously diagnosed with any of the following WHO systemic mastocytosis (SM) sub-classifications: cutaneous mastocytosis only, indolent SM, smoldering SM, SM with associated hematological neoplasm, aggressive SM, mast cell leukemia, mast cell sarcoma
Patient diagnosed with other myelo- or lympho-proliferative diseases, e.g., myelodysplastic syndrome, myeloproliferative neoplasm, etc
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If 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.

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