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A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies

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

Record History

The 50 most recent of 58 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Completion pushed from Mar 3, 2027 to Jun 30, 2027 · Eligibility criteria shortened, about 33 words · Secondary endpoints: details revised at 4 of 6 entries · 1 more Show 4 more changesShow less
    • Completion pushed from Mar 3, 2027 to Jun 30, 2027
    • Eligibility criteria shortened, about 33 words
    • Secondary endpoints: details revised at 4 of 6 entries
    • Site details revised at 1 of 32 sites
  2. Site details revised at 1 of 32 sitesv57
  3. 3 versions Re-verified since May 7, 2026, no change to tracked fieldsv54-v56
  4. Completion date: Mar 19, 2027 to Mar 3, 2027v53
  5. Re-verified, no change to tracked fieldsv52
Show 43 earlier versionsHide 43 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 200 to confirmed 196 · Site details revised at 32 of 32 sitesv51 Show 2 more changesShow less
    • Enrollment target: estimated 200 to confirmed 196
    • Site details revised at 32 of 32 sites
  2. Site details revised at 13 of 32 sitesv50
  3. Site details revised at 1 of 32 sitesv49
  4. Re-verified, no change to tracked fieldsv48
  5. Primary completion date: Oct 8, 2024 to Oct 30, 2026v47
  6. Re-verified, no change to tracked fieldsv46
  7. Site details revised at 9 of 32 sitesv45
  8. Re-verified, no change to tracked fieldsv44
  9. Primary completion date changed from estimate of Aug 5, 2026 to Oct 8, 2024v43
  10. Re-verified, no change to tracked fieldsv42
  11. Primary completion date: Mar 5, 2025 to Aug 5, 2026v41
  12. Study sites: 31 to 32v40
  13. Re-verified, no change to tracked fieldsv39
  14. Completion date: Mar 5, 2026 to Mar 19, 2027 Eligibility criteria expanded, about 109 words · Secondary endpoints: details revised at 3 of 6 entries · Study sites revised (31)v38 Show 3 more changesShow less
    • Eligibility criteria expanded, about 109 words
    • Secondary endpoints: details revised at 3 of 6 entries
    • Study sites revised (31)

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 30 to 31v37
  16. 3 versions Re-verified since Dec 4, 2024, no change to tracked fieldsv34-v36
  17. Enrollment target: 150 to 200v33
  18. 3 versions Re-verified since Aug 13, 2024, no change to tracked fieldsv30-v32
  19. Primary completion date: May 15, 2024 to Mar 5, 2025 Interventions: Azacitidine (AZA) (Drug), Cytarabine (Drug), Daunorubicin or Idarubicin (Drug), JNJ-75276617 (Drug), Venetoclax (VEN) (Drug) to Azacitidine (AZA) (Drug), Bleximenib (Drug), Cytarabine (Drug), Daunorubicin or Idarubicin (Drug), Venetoclax (VEN) (Drug) · Eligibility criteria shortened, about 14 words · Secondary endpoints: 10 to 6 · 2 morev29 Show 5 more changesShow less
    • Interventions: Azacitidine (AZA) (Drug), Cytarabine (Drug), Daunorubicin or Idarubicin (Drug), JNJ-75276617 (Drug), Venetoclax (VEN) (Drug) to Azacitidine (AZA) (Drug), Bleximenib (Drug), Cytarabine (Drug), Daunorubicin or Idarubicin (Drug), Venetoclax (VEN) (Drug)
    • Eligibility criteria shortened, about 14 words
    • Secondary endpoints: 10 to 6
    • Study description shortened, about 184 words
    • Study sites revised (30)

    See this version in full on ClinicalTrials.gov ↗

  20. Study sites: 29 to 30v28
  21. Re-verified, no change to tracked fieldsv27
  22. Completion date: Mar 30, 2026 to Mar 5, 2026v26
  23. Study sites revised (29)v25 See this version in full on ClinicalTrials.gov ↗
  24. Study sites revised (29)v24 See this version in full on ClinicalTrials.gov ↗
  25. Re-verified, no change to tracked fieldsv23
  26. Completion date: Jan 2, 2026 to Mar 30, 2026v22
  27. Re-verified, no change to tracked fieldsv21
  28. Study sites revised (29)v20 See this version in full on ClinicalTrials.gov ↗
  29. Study sites: 28 to 29v19
  30. Study sites: 26 to 28v18
  31. Study sites: 24 to 26v17
  32. Re-verified, no change to tracked fieldsv16
  33. Study sites revised (24)v15 See this version in full on ClinicalTrials.gov ↗
  34. Site details revised at 1 of 24 sitesv14
  35. Study sites: 21 to 24 Interventions: Azacitidine (AZA) (Drug), JNJ-75276617 (Drug), Venetoclax (VEN) (Drug) to Azacitidine (AZA) (Drug), Cytarabine (Drug), Daunorubicin or Idarubicin (Drug), JNJ-75276617 (Drug), Venetoclax (VEN) (Drug) · Study arms: 1 to 3v13 Show 2 more changesShow less
    • Interventions: Azacitidine (AZA) (Drug), JNJ-75276617 (Drug), Venetoclax (VEN) (Drug) to Azacitidine (AZA) (Drug), Cytarabine (Drug), Daunorubicin or Idarubicin (Drug), JNJ-75276617 (Drug), Venetoclax (VEN) (Drug)
    • Study arms: 1 to 3
  36. Study sites: 32 to 21v12
  37. Site details revised at 2 of 32 sitesv11
  38. Study sites revised (32)v10 See this version in full on ClinicalTrials.gov ↗
  39. Study sites: 31 to 32v9
  • 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 determine the recommended Phase 2 dose (RP2D) candidate(s) of bleximenib in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of bleximenib in combination with AML directed therapies at the RP2D(s) (dose expansion).
Trial Details
NCT Number NCT05453903
Lead Sponsor Janssen Research & Development, LLC
Conditions Leukemia, Myeloid, Acute
Enrollment 196 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov