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Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial sites expanded: 30 → 34 locations
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 8 of 17 entries
    • Study description expanded, about 3 words
  2. Study sites: 28 to 30v8
  3. Trial sites expanded: 24 → 28 locationsv7
  4. Trial sites expanded: 16 → 24 locationsv6
  5. Trial sites expanded: 4 → 16 locationsv5
  6. Study sites: 2 to 4
    • Start date changed from estimate of May 4, 2026 to Apr 28, 2026
    v4
  7. Recruitment opened
    • Study sites: 0 to 2
    v3
  8. Start date: Jun 4, 2026 to May 4, 2026v2
  9. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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) with Ph+ CML-CP. The study will evaluate the efficacy and safety of asciminib in pediatric formulation (weigh-based dose, fed state) or adult formulation (fasted) in newly diagnosed and resistant or intolerant Ph+ CML-CP with or without T315I mutation.
Trial Details
NCT Number NCT07354074
Lead Sponsor Novartis Pharmaceuticals
Conditions
(from sponsor)		 Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive
Related terms Bronchiolitis Obliterans Syndrome, Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov