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A Study of JNJ-90189892 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 Enrollment closed, study ongoing · Final enrollment: 85 participants (planned 155) · Completion moved earlier from Nov 21, 2028 to Feb 9, 2028 · 3 more Show 6 more changesShow less
    • Enrollment closed, study ongoing
    • Final enrollment: 85 participants (planned 155)
    • Completion moved earlier from Nov 21, 2028 to Feb 9, 2028
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 7 of 13 entries
    • Site details revised at 9 of 9 sites
  2. 2 versions Re-verified since Jul 2, 2026, no change to tracked fieldsv22-v23
  3. Study sites revised (9)v21 See this version in full on ClinicalTrials.gov ↗
  4. 2 versions Re-verified since Apr 9, 2026, no change to tracked fieldsv19-v20
  5. Enrollment increased: 100 → 155 participants Trial arms changed: 1 → 2 · Completion date: Dec 1, 2028 to Nov 21, 2028 · Interventions: JNJ-90189892 (Drug) to Azacitadine (AZA) (Drug), JNJ-90189892 (Drug), Venetoclax (VEN) (Drug) · 2 morev18 Show 5 more changesShow less
    • Trial arms changed: 1 → 2
    • Completion date: Dec 1, 2028 to Nov 21, 2028
    • Interventions: JNJ-90189892 (Drug) to Azacitadine (AZA) (Drug), JNJ-90189892 (Drug), Venetoclax (VEN) (Drug)
    • Eligibility criteria expanded, about 54 words
    • Secondary endpoints: 11 to 13

    See this version in full on ClinicalTrials.gov ↗

Show 16 earlier versionsHide 16 earlier versions
  1. Study sites: 8 to 9v17
  2. 2 versions Re-verified since Sep 11, 2025, no change to tracked fieldsv15-v16
  3. Study sites: 6 to 8v14
  4. 2 versions Re-verified since Jul 17, 2025, no change to tracked fieldsv12-v13
  5. Study sites: 5 to 6v11
  6. Study sites: 4 to 5v10
  7. Study sites: 3 to 4v9
  8. Study sites: 2 to 3v8
  9. Re-verified, no change to tracked fieldsv7
  10. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Mar 6, 2025 to Mar 21, 2025v6 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Mar 6, 2025 to Mar 21, 2025
  11. Re-verified, no change to tracked fieldsv5
  12. Start date: Feb 28, 2025 to Mar 6, 2025v4
  13. Re-verified, no change to tracked fieldsv3
  14. Start date: Mar 31, 2025 to Feb 28, 2025v2
  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 effective dose (recommended Phase 2 dose\[s\] \[RP2Ds\]) that can be safely administered, and dosing regimens of JNJ-90189892 in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R higher-risk type of myelodysplastic neoplasms (MDS \[type of cancer of the blood and bone marrow, which does not respond to treatment or comes back after treatment\]). 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 at the RP2D regimen(s). The purpose of Part 3 and 4 is to assess the effective dose (recommended Phase 2 combination dose \[RP2CD\]) that can be safely administered, and dosing regimens of JNJ-90189892 in combination with azacitadine (AZA) + venetoclax (VEN) in participants with R/R AML (part 3) and newly diagnosed (ND) AML (part 4).
Trial Details
NCT Number NCT06651229
Lead Sponsor Janssen Research & Development, LLC
Conditions Leukemia, Myeloid, Acute, Myelodysplastic Neoplasms
Enrollment 85 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov