Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP
Recruiting now · Phase 2
Conditions studied: Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive
In brief
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.
Key facts
- Study ID
- NCT07354074
- Run by
- Novartis Pharmaceuticals
- People needed
- 50
- Starts
- 2026-04-28
- Expected to finish
- 2033-02-23
- Last updated by the study team
- 2026-07-24
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (enrolling)
- Columbia University Medical Center New York Presbyterian — New York, New York, United States (enrolling)
- Seattle Childrens Hospital — Seattle, Washington, United States (enrolling)
- Novartis Investigative Site — Brisbane, Queensland, Australia (enrolling)
- Novartis Investigative Site — North Adelaide, South Australia, Australia (enrolling)
- Novartis Investigative Site — Edmonton, Alberta, Canada (enrolling)
- Novartis Investigative Site — Montreal, Quebec, Canada (enrolling)
- Novartis Investigative Site — Zhengzhou, Henan, China (enrolling)
- Novartis Investigative Site — Tianjin, China (enrolling)
- Novartis Investigative Site — Marseille, France (enrolling)
- Novartis Investigative Site — Paris, France (enrolling)
- Novartis Investigative Site — Poitiers, France (enrolling)
- Novartis Investigative Site — Strasbourg, France (enrolling)
- Novartis Investigative Site — Roma, RM, Italy (enrolling)
- Novartis Investigative Site — Yokohama, Kanagawa, Japan (enrolling)
- Novartis Investigative Site — Fukuoka, Japan (enrolling)
- Novartis Investigative Site — Saitama, Japan (enrolling)
- Novartis Investigative Site — Utrecht, Netherlands (enrolling)
- Novartis Investigative Site — Gdansk, Poland (enrolling)
- Novartis Investigative Site — Wroclaw, Poland (enrolling)
- Novartis Investigative Site — Seoul, South Korea (enrolling)
- Novartis Investigative Site — Seoul, South Korea (enrolling)
- Novartis Investigative Site — Barcelona, Spain (enrolling)
- Novartis Investigative Site — Madrid, Spain (enrolling)
Full record on ClinicalTrials.gov
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