Asciminib Roll-over Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Asciminib single agent: Taken orally, twice daily (BID) or once daily (QD), in fasting state
Imatinib: Taken orally, once daily, in the morning with low-fat meal
Nilotinib: Taken orally, twice daily, on an empty stomach
Bosutinib: Taken orally, once daily, with food
Dasatinib: Taken orally, once daily in a fasted state, 1 or 2 hours before a meal
Asciminib single agent pediatric formulation: Pediatric participants receive a body weight adjusted dose of 1.3 mg/kg of pediatric film coated granules with food twice daily (b.i.d.) or 2.6 mg/kg once daily (q.d.) in the morning.
Study summary
This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment
Eligibility
Primary outcome measure(s)
- Number of participants with adverse events (AEs) and serious adverse events (SAEs) — 8 years
All AEs and SAEs will be tabulated and listed for participants in the Safety Set by treatment group. From day of first administration of study treatment to 30 days after the last study treatment.
Trial sites (85)
| Facility | City | Region | Status |
|---|---|---|---|
| Michigan Med University of Michigan | Ann Arbor | Michigan | Recruiting |
| Memorial Sloan Kettering | New York | New York | Recruiting |
| Oregon Health Sciences University | Portland | Oregon | Active Not Recruiting |
| Texas Oncology | Dallas | Texas | Recruiting |
| Uni Of TX MD Anderson Cancer Cntr | Houston | Texas | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | Recruiting |
| Novartis Investigative Site | CABA | Buenos Aires | Recruiting |
| Novartis Investigative Site | Capital Federal | Argentina | Recruiting |
| Novartis Investigative Site | Graz | Austria | Recruiting |
| Novartis Investigative Site | Vienna | Austria | Recruiting |
| Novartis Investigative Site | Rio de Janeiro | Rio de Janeiro | Completed |
| Novartis Investigative Site | São Paulo | São Paulo | Completed |
| Novartis Investigative Site | São Paulo | São Paulo | Completed |
| Novartis Investigative Site | Varna | Bulgaria | Recruiting |
| Novartis Investigative Site | Montreal | Quebec | Recruiting |
| Novartis Investigative Site | Chongqing | Chongqing Municipality | Recruiting |
| Novartis Investigative Site | Guangzhou | Guangdong | Recruiting |
| Novartis Investigative Site | Zhengzhou | Henan | Recruiting |
| Novartis Investigative Site | Wuhan | Hubei | Recruiting |
| Novartis Investigative Site | Changchun | Jilin | Recruiting |
| Novartis Investigative Site | Xian | Shanxi | Recruiting |
| Novartis Investigative Site | Chengdu | Sichuan | Completed |
| Novartis Investigative Site | Beijing | China | Active Not Recruiting |
| Novartis Investigative Site | Beijing | China | Recruiting |
| Novartis Investigative Site | Shanghai | China | Active Not Recruiting |
| Novartis Investigative Site | Shenyang | China | Recruiting |
| Novartis Investigative Site | Tianjin | China | Recruiting |
| Novartis Investigative Site | Ostrava | Poruba | Recruiting |
| Novartis Investigative Site | Brno | Czechia | Recruiting |
| Novartis Investigative Site | Copenhagen | Denmark | Completed |
| Novartis Investigative Site | Bordeaux | France | Recruiting |
| Novartis Investigative Site | Lyon | France | Recruiting |
| Novartis Investigative Site | Marseille | France | Recruiting |
| Novartis Investigative Site | Nantes | France | Recruiting |
| Novartis Investigative Site | Paris | France | Recruiting |
| Novartis Investigative Site | Vandœuvre-lès-Nancy | France | Recruiting |
| Novartis Investigative Site | Frankfurt am Main | Hesse | Recruiting |
| Novartis Investigative Site | Jena | Thuringia | Recruiting |
| Novartis Investigative Site | Berlin | Germany | Recruiting |
| Novartis Investigative Site | Kiel | Germany | Recruiting |
+ 45 more sites — see the full list on the official registry below.
On this site
📄 Gleevec (imatinib) drug profile → 📄 Tasigna (nilotinib) drug profile → 📄 Sprycel (dasatinib) drug profile →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 NCT04877522 on ClinicalTrials.gov ↗ ← All trials in Italy