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NCT07354074 · ClinicalTrials.gov registry record · Phase 2
Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT07354074: Recruiting Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT07354074 is a Phase 2 study that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07354074, a Phase 2 study, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study 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.
Primary Outcome
MMR is defined as BCR::ABL1 IS ≤0.1%. MMR is defined as a ≥ 3.0 log reduction in BCR::ABL1 transcripts compared to the standardized baseline equivalent to ≤ 0.1 % BCR::ABL1/ABL % by international scale as measured by RQ-PCR.
Interventions
- DRUG Asciminib single agent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-04-28 |
| Est. Completion | 2033-02-23 |
| Phase | Phase 2 |
What NCT07354074 shows while recruiting
NCT07354074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Asciminib single agent is the first listed.
NCT07354074 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07354074 about?
NCT07354074 is a clinical study titled "Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP". 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 resist...
What is the current status of trial NCT07354074?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2026-04-28. Estimated completion is 2033-02-23.
What interventions are being tested in trial NCT07354074?
The interventions under investigation include: Asciminib single agent (DRUG).
Who is sponsoring clinical trial NCT07354074?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07354074's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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