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cAMeLot-1NCT04811560

A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary completion moved at least 1 year 10 months later.

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Record History

The 50 most recent of 70 versions: 37 with changes below, 13 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Feb 26, 2027 to Dec 29, 2028
    • Site details revised at 5 of 102 sites
  2. Primary endpoints: details revised at 1 of 4 entries Show 4 more changesShow less
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: details revised at 4 of 11 entries
    • Site details revised at 3 of 102 sites
    • Publications: details revised at 1 of 1 entry
  3. Study sites revised (102)v68
  4. Site details revised at 2 of 102 sitesv67
  5. Study sites: 103 to 102v65
  6. Site details revised at 1 of 103 sitesv64
  7. Primary completion pushed from Jun 30, 2026 to Feb 26, 2027v63
  8. Study sites revised (103)
    • Eligibility criteria shortened, about 2 words
    v62
  9. Primary completion pushed from Feb 16, 2026 to Jun 30, 2026
    • Study completion pushed from May 26, 2028 to Sep 22, 2030
    • Enrollment target: 400 to 420
    • Study sites: 101 to 103
    v61
  10. Study sites: 100 to 101v60
  11. Study sites: 99 to 100v59
  12. Study sites: 97 to 99
    • Eligibility criteria revised
    v58
  13. Study sites: 96 to 97
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints revised (11)
    • Study title expanded, about 1 word
    v57
  14. Study sites: 92 to 96
    • Study completion date: Oct 31, 2027 to May 26, 2028
    v56
  15. Study sites: 82 to 92v55
  16. Study sites: 81 to 82v54
  17. Study sites: 77 to 81v53
  18. Study sites: 70 to 77v52
  19. Study sites: 64 to 70v50
  20. Study sites: 60 to 64v49
  21. Study sites: 54 to 60
    • Eligibility criteria shortened, about 45 words
    • Secondary endpoints: 15 to 11
    v47
  22. Enrollment target: 350 to 400
    • Study sites: 31 to 54
    • Study completion date: Oct 30, 2027 to Oct 31, 2027
    v46
  23. Study sites: 29 to 31v45
  24. Study sites: 26 to 29v44
  25. Study sites: 25 to 26v43
  26. Enrollment target: 150 to 350v42 Show 8 more changesShow less
    • Primary endpoints: 3 to 4
    • Study sites: 24 to 25
    • Study completion date: Feb 16, 2026 to Oct 30, 2027
    • Interventions: JNJ-75276617 (Drug) to Bleximenib (Drug)
    • Secondary endpoints: 4 to 15
    • Study description shortened, about 181 words
    • Eligibility criteria shortened, about 5 words
    • Study title expanded, about 2 words
  27. Phase: Phase 1 to Phase 1/2v39
  28. Primary and study completion dates pushed to Feb 16, 2026v38 Show 5 more changesShow less
    • Enrollment target: 110 to 150
    • Eligibility criteria expanded, about 49 words
    • Secondary endpoints: 7 to 4
    • Study description revised
    • Study sites revised (24)
  29. Study completion date: Jun 20, 2025 to Oct 16, 2025
    • Study sites revised (24)
    v35
  30. Study sites revised (24)v34
  31. Site details revised at 1 of 24 sitesv29
  32. Site details revised at 1 of 24 sitesv28
  33. Study sites: 29 to 24v26
  34. Study completion date: Jun 15, 2026 to Jun 20, 2025v25
  35. Study completion date: Jun 20, 2025 to Jun 15, 2026
    • Study sites revised (29)
    v24
  36. Study sites revised (29)v23
  37. Study sites: 27 to 29v21
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Phase 1: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Timeframe: Up to 4 years and 9 months
Phase 1: Number of Participants with AEs by Severity
Timeframe: Up to 4 years and 9 months
Phase 1: Part 1: Percentage of Participants with Dose-Limiting Toxicity (DLT)
Timeframe: Up to 28 days Cycle 1
Phase 2: Rate of Complete Remission or Complete Remission with Partial Hematologic Recovery (CR/CRh)
Timeframe: Up to 4 years and 9 months

Secondary (11)

Phase 1 and 2: Plasma Concentration of Bleximenib
Phase 1 and 2: Overall Response Rate (ORR)
Phase 1: Duration of Response (DOR)
Phase 1 and 2: Time To Response (TTR)
Phase 2: Duration of Complete Response (CR)/Complete Remission With Partial Hematologic Recovery (CRh)
Show 6 moreShow less
Phase 2: Time To CR/CRh
Phase 2: Event-free survival (EFS)
Phase 2: Overall survival (OS)
Phase 2: Measurable Residual Disease (MRD) Negativity Among Participants Achieving CR/CRh/CRi
Phase 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Phase 2: Number of Participants Reporting Transfusion Independence

Arms and interventions

BleximenibExperimental

Participants in Phase 1 Part 1 (dose escalation) will receive bleximenib orally. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET) until the recommended Phase 2 Doses (RP2Ds) have been identified. Participants in Phase 1 Part 2 (dose expansion) will receive bleximenib orally at the RP2D(s) determined in Part 1. In Phase 2 participants will receive bleximenib at the RP2D to evaluate anti-leukemia activity and demonstrate acceptable safety at the RP2D(s).

Drugs: Bleximenib

Sites

102 sites in 13 countries

United States 26, France 13, China 12, Japan 11, Spain 9, United Kingdom 8, Brazil 6, Israel 4, Australia 3, Canada 3, South Korea 3, Taiwan 3, Belgium 1