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A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia

StatusCompleted
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Trial completed · Final enrollment: 6 participants (planned 10) · Primary completion date changed from estimate of Sep 29, 2026 to Jul 21, 2026 · 3 more Show 6 more changesShow less
    • Trial completed
    • Final enrollment: 6 participants (planned 10)
    • Primary completion date changed from estimate of Sep 29, 2026 to Jul 21, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
  2. Minor Primary completion pushed from Jun 14, 2026 to Sep 29, 2026 Completion pushed from Jul 13, 2026 to Sep 29, 2026v8 Show 1 more changeShow less
    • Completion pushed from Jul 13, 2026 to Sep 29, 2026
  3. Minor 6 versions Re-verified since Jan 15, 2026, no change to tracked fieldsv2-v7
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to assess how the body absorbs, breaks down (metabolism), and removes (excretes) radiolabeled bleximenib (a drug molecule that has been chemically bonded with a radioactive isotope which emits radiation making it easier to track in the body) in participants with acute leukemia (highly aggressive blood cancer typically characterized by large numbers of immature white blood cells in the bone marrow).
Trial Details
NCT Number NCT07295951
Lead Sponsor Janssen Research & Development, LLC
Conditions Acute Lymphoblastic Leukemia, Acute Leukemias, Acute Myeloid Leukemia
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov