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Chronic Myelogenous Leukemia / Asciminib single agent / Leukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive · Phase 2 Trial
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is an active Phase 2 trial registration of asciminib in pediatric Ph+ CML-CP patients (ages 1–17 years), including both newly diagnosed and resistant or intolerant cases, with major molecular response at 48 weeks as the primary endpoint. No results have been posted to the registry; the study remains in the recruitment phase and provides only design and population information.
Phase 2, Interventional, Single Group, Open label, Treatment purpose. Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive; age from 1 Year; to 18 Years. Intervention: Single arm study. n = 50. 28 sites across 13 countries.
This is an active Phase 2 trial registration of asciminib in pediatric Ph+ CML-CP patients (ages 1–17 years), including both newly diagnosed and resistant or intolerant cases, with major molecular response at 48 weeks as the primary endpoint. No results have been posted to the registry; the study remains in the recruitment phase and provides only design and population information.
This is a registry record only; no efficacy or safety results are reported.
The source did not state who this applies to in practice.
This is an active Phase 2 trial registration with no results reported; it describes a planned study of asciminib in pediatric Ph+ CML, a population lacking established efficacy and safety data.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07354074). This is a study registration, not published results. Lead sponsor: Novartis Pharmaceuticals. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 50 participants (ESTIMATED). Conditions: Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive. Interventions: DRUG: Asciminib single agent. Primary outcome measures: MMR at Week 48 , 48 weeks. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.