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Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia
NCT04925479 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Asciminib Pediatric formulation group
- DRUG Asciminib Adult formulation group
Study Locations (20)
Other
- Novartis Investigative Site — Beijing
- Novartis Investigative Site — Shanghai
- Novartis Investigative Site — Tianjin
- Novartis Investigative Site — Bordeaux
- Novartis Investigative Site — Lille
- Novartis Investigative Site — Paris
- Novartis Investigative Site — Poitiers
- Novartis Investigative Site — Erlangen
- Novartis Investigative Site — Essen
- Novartis Investigative Site — Hamburg
Massachusetts
- Dana Farber Cancer Institute — Boston
- Dana Farber Cancer Institute — Boston
Indiana
- Indiana UH Riley H for CIU — Indianapolis
Mississippi
- University of Mississippi Medical Center — Jackson
New York
- Columbia University Medical Center New York Presbyterian — New York
Ohio
- Cinn Children Hosp Medical Center — Cincinnati
Pennsylvania
- Childrens Hospital of Philadelphia — Philadelphia
Texas
- Uni Of Texas MD Anderson Cancer Ctr — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2021-12-27 |
| Est. Completion | 2031-11-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04925479
The ClinicalTrials.gov registry entry for NCT04925479 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Myeloid Leukemia, Philadelphia Positive appearing as the primary indexed condition, and to 2 interventions — of which Asciminib Pediatric formulation group is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04925479 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, Massachusetts, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04925479 about?
NCT04925479 is a clinical study titled "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...
What is the current status of trial NCT04925479?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2021-12-27. Estimated completion is 2031-11-01.
What conditions does trial NCT04925479 study?
This clinical trial studies the following conditions: Myeloid Leukemia, Philadelphia Positive. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04925479?
The interventions under investigation include: Asciminib Pediatric formulation group (DRUG), Asciminib Adult formulation group (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04925479?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04925479 being conducted?
This trial has 20 study locations across Indiana, Massachusetts, Mississippi, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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