Clinical Trials

Inclusion Criteria:

• Written informed consent.
• Age ≥ 18 years.
• Presenting with at least one of the three criteria below as evidence of systemic MCA:
  • 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 sBT 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 sBT 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 SM sub-classifications:
  • CM only;
  • ISM;
  • SSM;
  • SM-AHN;
  • ASM;
  • MCL;
  • MC sarcoma.
• Patient diagnosed with other myelo- or lympho-proliferative diseases; e.g., myelodysplastic syndrome, myeloproliferative neoplasm, etc.