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Screening Study for KIT D816V Mutated Mast Cell Disease in Select Populations

Study acronym: POLARIS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 2 changed
See other at-risk trials from Blueprint Medicines

Record History

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  1. Trial sites expanded: 22 → 26 locations
    • Eligibility criteria expanded, about 17 words
  2. Primary endpoint(s) modifiedv9 Show 4 more changesShow less
    • Enrollment increased: 450 → 750 participants
    • Trial sites expanded: 19 → 22 locations
    • Trial arms changed: 3 → 4
    • Eligibility criteria expanded, about 78 words
  3. Study sites: 18 to 19v8
  4. Study sites: 17 to 18v7
  5. Study sites: 16 to 17v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 14 to 16v5
  2. Study sites: 12 to 14v4
  3. Study sites: 8 to 12v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 8
    • Start date changed from estimate of Sep 30, 2025 to Oct 17, 2025
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Blueprint Medicines
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This is a multicenter screening study to characterize the prevalence of the KIT D816V mutation in participants with suspected clonal mast cell disease.
Trial Details
NCT Number NCT07143669
Lead Sponsor Blueprint Medicines Corporation
Conditions
(from sponsor)		 Clonal Mast Cell Disease, KIT D816V Mutation, Suspected KITD816V Mutated Clonal Mast Cell Disease
Related terms Leukemia, Myelomonocytic, Chronic, Mastocytosis, Mastocytosis, Cutaneous, Postural Orthostatic Tachycardia Syndrome, red meat allergy
Enrollment 750 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov