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

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 ID
NCT07354074
Phase
PHASE2
Sponsor
Novartis Pharmaceuticals
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Asciminib single agent
Locations (sample)
  • New Brunswick, New Jersey, United States|40.48622,-74.45182
  • New York, New York, United States|40.71427,-74.00597
  • Cincinnati, Ohio, United States|39.12711,-84.51439
  • Seattle, Washington, United States|47.60621,-122.33207
  • Brisbane, Queensland, Australia|-27.46794,153.02809

Key Eligibility Criteria

  • Participants eligible for inclusion in this study must meet all of the following criteria:
  • Signed informed consent must be obtained prior to participation in the study.
  • Male or female participants 1 and \< 18 years of age at study enrollment
  • Diagnosis of CML-CP (Apperley et al 2025) with cytogenetic confirmation of Philadelphia positive (Ph+) chromosome

For full eligibility, visit ClinicalTrials.gov.

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