Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP
Condition(s) studied
Investigational drug(s) / intervention(s)
Asciminib single agent: Asciminib (labelled as ABL001) administered as 40 mg tablet (adult formulation) or as 1 mg film-coated granules mini-tablets (pediatric formulation)
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.
Eligibility
Primary outcome measure(s)
- MMR at Week 48 — 48 weeks
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.
Trial sites (30)
| Facility | City | Region | Status |
|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | Recruiting |
| Columbia University Medical Center New York Presbyterian | New York | New York | Recruiting |
| Cinn Children Hosp Medical Center | Cincinnati | Ohio | Recruiting |
| Seattle Childrens Hospital | Seattle | Washington | Recruiting |
| Novartis Investigative Site | Brisbane | Queensland | Recruiting |
| Novartis Investigative Site | North Adelaide | South Australia | Recruiting |
| Novartis Investigative Site | Rio de Janeiro | Rio de Janeiro | Recruiting |
| Novartis Investigative Site | Barretos | São Paulo | Recruiting |
| Novartis Investigative Site | São Paulo | São Paulo | Recruiting |
| Novartis Investigative Site | Edmonton | Alberta | Recruiting |
| Novartis Investigative Site | Montreal | Quebec | Recruiting |
| Novartis Investigative Site | Zhengzhou | Henan | Recruiting |
| Novartis Investigative Site | Tianjin | China | Recruiting |
| Novartis Investigative Site | Marseille | France | Recruiting |
| Novartis Investigative Site | Paris | France | Recruiting |
| Novartis Investigative Site | Poitiers | France | Recruiting |
| Novartis Investigative Site | Strasbourg | France | Recruiting |
| Novartis Investigative Site | Frankfurt am Main | Hesse | Recruiting |
| Novartis Investigative Site | Erlangen | Germany | Recruiting |
| Novartis Investigative Site | Roma | RM | Recruiting |
| Novartis Investigative Site | Yokohama | Kanagawa | Recruiting |
| Novartis Investigative Site | Fukuoka | Japan | Recruiting |
| Novartis Investigative Site | Saitama | Japan | Recruiting |
| Novartis Investigative Site | Utrecht | Netherlands | Recruiting |
| Novartis Investigative Site | Gdansk | Poland | Recruiting |
| Novartis Investigative Site | Wroclaw | Poland | Recruiting |
| Novartis Investigative Site | Seoul | South Korea | Recruiting |
| Novartis Investigative Site | Seoul | South Korea | Recruiting |
| Novartis Investigative Site | Barcelona | Spain | Recruiting |
| Novartis Investigative Site | Madrid | Spain | Recruiting |
More Novartis Pharmaceuticals trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07354074 on ClinicalTrials.gov ↗ ← All trials in Italy