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Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion moved earlier from Nov 1, 2031 to Oct 1, 2031 Site details revised at 2 of 39 sites Show 1 more changeShow less
    • Site details revised at 2 of 39 sites
  2. Primary completion date: Sep 21, 2027 to Sep 2, 2027 Completion date: Nov 1, 2031 to Oct 1, 2031 · Eligibility criteria expanded, about 25 words · Secondary endpoints: details revised at 2 of 3 entries · 2 more Show 5 more changesShow less
    • Completion date: Nov 1, 2031 to Oct 1, 2031
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Study description revised
    • Site details revised at 35 of 39 sites
  3. Site details revised at 3 of 39 sitesv45
  4. Primary completion pushed from Jun 16, 2026 to Sep 21, 2027 Site details revised at 1 of 39 sites · Eligibility criteria shortened, about 1 wordv44 Show 2 more changesShow less
    • Site details revised at 1 of 39 sites
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Enrollment target: 44 to 34 Study sites: 40 to 39 · Primary completion date: Jun 30, 2026 to Jun 16, 2026v43 Show 2 more changesShow less
    • Study sites: 40 to 39
    • Primary completion date: Jun 30, 2026 to Jun 16, 2026
Show 41 earlier versionsHide 41 earlier versions
  1. Site details revised at 6 of 40 sitesv42
  2. Site contacts updated at 1 of 40 sitesv41
  3. Study sites: 39 to 40v40
  4. Primary completion date: Jul 21, 2025 to Jun 30, 2026 Enrollment target: 34 to 44 · Study sites: 38 to 39v39 Show 2 more changesShow less
    • Enrollment target: 34 to 44
    • Study sites: 38 to 39
  5. Study sites: 36 to 38 Primary completion date: Jun 30, 2026 to Jul 21, 2025v38 Show 1 more changeShow less
    • Primary completion date: Jun 30, 2026 to Jul 21, 2025
  6. Study sites revised (36)v37 See this version in full on ClinicalTrials.gov ↗
  7. Eligibility criteria expanded, about 16 words Site details revised at 5 of 36 sitesv36 Show 1 more changeShow less
    • Site details revised at 5 of 36 sites

    See this version in full on ClinicalTrials.gov ↗

  8. Site contacts updated at 1 of 36 sitesv35
  9. Study sites: 35 to 36v34
  10. Study sites: 34 to 35v33
  11. Study sites: 33 to 34 Primary completion date: Sep 14, 2026 to Jun 30, 2026 · Completion date: Jan 27, 2031 to Nov 1, 2031v32 Show 2 more changesShow less
    • Primary completion date: Sep 14, 2026 to Jun 30, 2026
    • Completion date: Jan 27, 2031 to Nov 1, 2031
  12. Study sites: 31 to 33 Completion date: Oct 4, 2030 to Jan 27, 2031v31 Show 1 more changeShow less
    • Completion date: Oct 4, 2030 to Jan 27, 2031
  13. Study sites: 30 to 31v30
  14. Study sites: 28 to 30v29
  15. Study sites: 27 to 28v28
  16. Primary completion date: Oct 17, 2025 to Sep 14, 2026 Study sites: 25 to 27 · Completion date: Nov 9, 2029 to Oct 4, 2030v27 Show 2 more changesShow less
    • Study sites: 25 to 27
    • Completion date: Nov 9, 2029 to Oct 4, 2030
  17. Site details revised at 1 of 25 sitesv26
  18. Primary completion date: Jun 13, 2025 to Oct 17, 2025 Completion date: Jul 6, 2029 to Nov 9, 2029 · Eligibility criteria expanded, about 8 words · Study description expanded, about 74 words · 1 morev25 Show 4 more changesShow less
    • Completion date: Jul 6, 2029 to Nov 9, 2029
    • Eligibility criteria expanded, about 8 words
    • Study description expanded, about 74 words
    • Study sites revised (25)

    See this version in full on ClinicalTrials.gov ↗

  19. Study sites: 24 to 25v24
  20. Primary completion date: Dec 4, 2025 to Jun 13, 2025 Completion date: Dec 27, 2029 to Jul 6, 2029v23 Show 1 more changeShow less
    • Completion date: Dec 27, 2029 to Jul 6, 2029
  21. Study sites: 23 to 24v22
  22. Enrollment target: 40 to 34 Study sites: 22 to 23v21 Show 1 more changeShow less
    • Study sites: 22 to 23
  23. Study sites: 21 to 22v20
  24. Study sites: 20 to 21v19
  25. Study sites: 19 to 20v18
  26. Study sites: 18 to 19v17
  27. Study sites: 16 to 18v16
  28. Study sites: 12 to 16 Primary completion date: Oct 27, 2025 to Dec 4, 2025 · Completion date: Nov 19, 2029 to Dec 27, 2029v15 Show 2 more changesShow less
    • Primary completion date: Oct 27, 2025 to Dec 4, 2025
    • Completion date: Nov 19, 2029 to Dec 27, 2029
  29. Study sites: 11 to 12 Eligibility criteria expanded, about 9 wordsv14 Show 1 more changeShow less
    • Eligibility criteria expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  30. Study sites: 10 to 11 Primary completion date: Nov 7, 2025 to Oct 27, 2025 · Completion date: Nov 30, 2029 to Nov 19, 2029v13 Show 2 more changesShow less
    • Primary completion date: Nov 7, 2025 to Oct 27, 2025
    • Completion date: Nov 30, 2029 to Nov 19, 2029
  31. Study sites: 9 to 10v12
  32. Study sites: 8 to 9v11
  33. Study sites: 6 to 8 Start date changed from estimate of Jan 10, 2022 to Dec 27, 2021v10 Show 1 more changeShow less
    • Start date changed from estimate of Jan 10, 2022 to Dec 27, 2021
  34. Primary completion date: Oct 27, 2025 to Nov 7, 2025 Completion date: Nov 19, 2029 to Nov 30, 2029 · Start date: Dec 30, 2021 to Jan 10, 2022v9 Show 2 more changesShow less
    • Completion date: Nov 19, 2029 to Nov 30, 2029
    • Start date: Dec 30, 2021 to Jan 10, 2022
  35. Start date: Nov 30, 2021 to Dec 30, 2021v8
  36. Study sites: 4 to 6v7
  37. Study sites: 3 to 4v6
  38. Primary completion date: Nov 7, 2025 to Oct 27, 2025 Completion date: Nov 30, 2029 to Nov 19, 2029v5 Show 1 more changeShow less
    • Completion date: Nov 30, 2029 to Nov 19, 2029
  39. Start date: Oct 18, 2021 to Nov 30, 2021 Study sites: 1 to 3v4 Show 1 more changeShow less
    • Study sites: 1 to 3
  40. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 30 to 40 · Study sites: 0 to 1 · Primary completion date: Oct 16, 2025 to Nov 7, 2025 · 2 morev3 Show 5 more changesShow less
    • Enrollment target: 30 to 40
    • Study sites: 0 to 1
    • Primary completion date: Oct 16, 2025 to Nov 7, 2025
    • Completion date: Nov 8, 2029 to Nov 30, 2029
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  41. Start date: Sep 3, 2021 to Oct 18, 2021v2
  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 aim of this study is to support development of asciminib in the pediatric population (1 to \<18 years) previously treated with one or more TKIs. Full extrapolation of the efficacy of asciminib from adult to pediatric patients will be conducted. Full extrapolation is based on the concept that CML in the pediatric population has the same pathogenesis, similar clinical characteristics and progression pattern as in adults.
Trial Details
NCT Number NCT04925479
Lead Sponsor Novartis Pharmaceuticals
Conditions Myeloid Leukemia, Philadelphia Positive
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov