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

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 ID
NCT04925479
Phase
PHASE1 / PHASE2
Sponsor
Novartis Pharmaceuticals
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Asciminib Pediatric formulation group
  • Asciminib Adult formulation group
Locations (sample)
  • Indianapolis, Indiana, United States|39.76838,-86.15804
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Jackson, Mississippi, United States|32.29876,-90.18481
  • New York, New York, United States|40.71427,-74.00597
  • Cincinnati, Ohio, United States|39.12711,-84.51439

Key Eligibility Criteria

  • Male or female participants:
  • Pediatric formulation group: ≥ 1 and less than 18 years of age at study entry.
  • Adult formulation group: ≥ 14 and less than 18 years of age and body weight of ≥ 40 kg at study entry.
  • Participants with Ph+ CML-CP must meet all of the following laboratory values at the screening visit. In the case where bone marrow blast and promy…

For full eligibility, visit ClinicalTrials.gov.

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