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A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Primary completion date changed from estimate of Nov 16, 2026 to Sep 2, 2026 · Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 5 of 11 entries Show 3 more changesShow less
    • Primary completion date changed from estimate of Nov 16, 2026 to Sep 2, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 5 of 11 entries
  2. Primary completion moved earlier from Jul 15, 2027 to Nov 16, 2026 Completion moved earlier from Jan 12, 2028 to Nov 16, 2026v23 Show 1 more changeShow less
    • Completion moved earlier from Jan 12, 2028 to Nov 16, 2026
  3. 2 versions Re-verified since Jun 4, 2026, no change to tracked fieldsv21-v22
  4. Enrollment reduced: 115 → 64 participants Trial status changed: Recruiting → Active, Not Recruiting · Site details revised at 9 of 9 sitesv20 Show 2 more changesShow less
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised at 9 of 9 sites
  5. 2 versions Re-verified since Mar 12, 2026, no change to tracked fieldsv18-v19
Show 16 earlier versionsHide 16 earlier versions
  1. Enrollment target: 100 to 115 Site details revised at 1 of 9 sitesv17 Show 1 more changeShow less
    • Site details revised at 1 of 9 sites
  2. Completion date: Aug 15, 2028 to Jan 12, 2028v16
  3. Re-verified, no change to tracked fieldsv15
  4. Study sites: 5 to 9v14
  5. Study sites: 7 to 5v13
  6. Re-verified, no change to tracked fieldsv12
  7. Study sites: 6 to 7v11
  8. Study sites: 4 to 6v10
  9. 2 versions Re-verified since Mar 29, 2025, no change to tracked fieldsv8-v9
  10. Study sites: 3 to 4v7
  11. Study sites: 2 to 3v6
  12. Re-verified, no change to tracked fieldsv5
  13. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Jan 15, 2025 to Jan 14, 2025v4 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Jan 15, 2025 to Jan 14, 2025
  14. Completion date: Jul 15, 2027 to Aug 15, 2028 Secondary endpoints: details revised at 1 of 11 entriesv3 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 11 entries
  15. Re-verified, no change to tracked fieldsv2
  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.
The purpose of Part 1 (Dose Escalation) of the study is to assess the safety and tolerability, and to identify the recommended Phase 2 dose\[s\] (RP2D\[s\]) in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) (that is a type of blood cancer that has come back after treatment/or has stopped responding to treatment) or R/R higher-risk type of myelodysplastic neoplasms (MDS, type of blood cancer). The purpose of Part 2 (Cohort Expansion) is to further assess the safety, tolerability and efficacy in participants with R/R AML or higher-risk types of MDS.
Trial Details
NCT Number NCT06618001
Lead Sponsor Janssen Research & Development, LLC
Conditions Leukemia, Myeloid, Acute, Myelodysplastic Neoplasms
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov