A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Study acronym: cAMeLot-2
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC
    • Trial sites expanded: 262 → 266 locations
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 1 of 9 entries
  2. Trial sites expanded: 257 → 262 locationsv23
  3. Trial sites expanded: 253 → 257 locationsv22
  4. Trial sites expanded: 250 → 253 locationsv21
  5. Study sites: 248 to 250v20
  6. Trial sites expanded: 239 → 248 locationsv19
  7. Study sites: 238 to 239v18
  8. Study sites: 227 to 238v17
  9. Study sites: 221 to 227v16
  10. Study sites: 212 to 221v15
  11. Study sites: 194 to 212v14
  12. Study sites: 181 to 194v13
  13. Study sites: 170 to 181
    • Secondary endpoints revised (9)
    • Eligibility criteria expanded, about 4 words
    • Study title expanded, about 2 words
    v12
  14. Study sites: 141 to 170v11
  15. Study sites: 139 to 141v10
  16. Study sites: 35 to 139
    • Eligibility criteria expanded, about 22 words
    v9
  17. Study sites: 34 to 35v8
  18. Study sites: 13 to 34v7
  19. Study sites: 11 to 13v6
  20. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 11
    • Start date changed from estimate of Apr 30, 2025 to Jun 4, 2025
    v5
  21. Study sites: 2 to 1v4
  22. Start date: May 2, 2025 to Apr 30, 2025v3
  23. Study sites: 0 to 2v2
  24. Study First Submitted
  • 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 bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.
Trial Details
NCT Number NCT06852222
Lead Sponsor Janssen Research & Development, LLC
Conditions
(from sponsor)		 Leukemia, Myeloid, Acute
Related terms Leukemia, Myeloid, Acute
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov