Actively Recruiting
Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP
Led by Novartis Pharmaceuticals · Updated on 2026-04-24
50
Participants Needed
2
Research Sites
355 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent prior to study participation
- Male or female participants aged 1 to under 18 years at enrollment
- Diagnosis of chronic myelogenous leukemia in chronic phase with Philadelphia positive chromosome
- Newly diagnosed within 3 months of screening or at high risk of resistance or intolerance to previous TKI treatment
- Evidence of typical BCR::ABL1 transcript (e14a2 and/or e13a2) suitable for standardized testing
- Karnofsky performance status 65 50% for participants 65 16 years old or Lansky performance score 65 50 for participants under 16 years at screening
You will not qualify if you...
- Known second chronic phase of CML after progression to accelerated or blast phase
- Previous hematopoietic stem-cell transplantation
- Planned allogeneic hematopoietic stem cell transplantation
- Presence of BCR::ABL1 mutation with known resistance to asciminib according to clinical guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Novartis Investigative Site
Brisbane, Queensland, Australia, 4101
Actively Recruiting
2
Novartis Investigative Site
Seoul, South Korea, 03080
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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