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A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia

Study acronym: CML
StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Primary and study completion pushed from Dec 2026 to Dec 2027
    • Enrollment increased: 200 → 250 participants
    • Study sites: 46 to 45
    v27
  2. Site details revised at 1 of 46 sitesv26
  3. Site contacts updated at 1 of 46 sitesv25
  4. Study sites: 44 to 46v24
  5. Study sites: 42 to 44v23
Show 21 earlier versionsHide 21 earlier versions
  1. Enrollment target: 180 to 200
    • Eligibility criteria expanded, about 27 words
    • Site contacts updated at 2 of 42 sites
    • Study arms: 4 to 3
    v22
  2. Study sites: 39 to 42v21
  3. Study sites: 38 to 39v20
  4. Study sites: 35 to 38v19
  5. Study sites: 34 to 35v18
  6. Site contacts updated at 3 of 34 sitesv17
  7. Study sites: 33 to 34v16
  8. Site details revised at 1 of 33 sitesv15
  9. Study sites: 32 to 33v14
  10. Study sites: 29 to 32v13
  11. Study sites: 28 to 29v12
  12. Re-verified, no change to tracked fieldsv11
  13. Study sites: 25 to 28v10
  14. Study sites: 24 to 25v9
  15. Enrollment target: 120 to 180v8 Show 5 more changesShow less
    • Study sites: 23 to 24
    • Eligibility criteria expanded, about 53 words
    • Secondary endpoints: 8 to 7
    • Primary endpoints revised (7)
    • Study description shortened, about 2 words
  16. Site contacts updated at 1 of 23 sitesv7
  17. Site details revised at 6 of 23 sitesv6
  18. Site details revised at 10 of 23 sitesv5
  19. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 23
    • Start date changed from estimate of May 2022 to May 22, 2022
    v4
  20. Study arms: 3 to 4v3
  21. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.
Trial Details
NCT Number NCT05304377
Lead Sponsor Enliven Therapeutics
Conditions
(from sponsor)		 Chronic Myeloid Leukemia, Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Cml
Related terms Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov