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NCT04925479 · ClinicalTrials.gov registry record · Phase 1
Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia
A Phase 1 study of Myeloid Leukemia, Philadelphia Positive, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 20
- Study locations
NCT04925479 is a Phase 1 study of Myeloid Leukemia, Philadelphia Positive that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 44 participants. The trial reports 20 study locations across 10 states.
The verdict
NCT04925479, a Phase 1 study of Myeloid Leukemia, Philadelphia Positive, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. 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 1,375 total studies on file at ClinicalTrials.gov.
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.
NCT04925479 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, Massachusetts, Indiana.
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.
What interventions are being tested in trial NCT04925479?
The interventions under investigation include: Asciminib Pediatric formulation group (DRUG), Asciminib Adult formulation group (DRUG).
Who is sponsoring clinical trial NCT04925479?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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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