Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Dzieci w wieku od 1 do poniżej 18 lat (lub od 14 lat i ważące co najmniej 40 kg, w zależności od formy leku).
- •Choroba jest w fazie przewlekłej (CP) białaczki szpikowej, potwierdzona badaniami.
- •Przed leczeniem w badaniu pacjent musiał przyjmować co najmniej jeden lek z grupy TKI.
- •Poprzednie leczenie lekiem TKI było nieskuteczne lub źle tolerowane.
- •Ogólny stan zdrowia pozwala na uczestnictwo w badaniu.
- •Prawidłowe wyniki badań krwi, nerek, wątroby i serca.
✗ Disqualifies
- •Obecność konkretnej mutacji genetycznej (T315I) lub innej mutacji powodującej oporność na lek.
- •Zaawansowana lub późniejsza faza białaczki.
- •Niewydolność kluczowych narządów (serca, płuc, nerek, wątroby, trzustki).
Simplified criteria — AI translation
Trial details
- Minimum age
- 1 Year
- Maximum age
- 17 Years
- Last updated (source)
- June 30, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (39)
Indiana UH Riley H for CIU
Indianapolis, United States
Dana Farber Cancer Institute
Boston, United States
University of Mississippi Medical Center
Jackson, United States
Columbia University Medical Center New York Presbyterian
New York, United States
Cinn Children Hosp Medical Center
Cincinnati, United States
Childrens Hospital of Philadelphia
Philadelphia, United States
Uni Of Texas MD Anderson Cancer Ctr
Houston, United States
University Of Utah
Salt Lake City, United States
Novartis Investigative Site
Hangzhou, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Tianjin, China
Novartis Investigative Site
Bordeaux, France
Novartis Investigative Site
Lille, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Poitiers, France
Novartis Investigative Site
Erlangen, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Athens, Greece
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Genova, Italy
Novartis Investigative Site
Monza, Italy
Novartis Investigative Site
Roma, Italy
Novartis Investigative Site
Torino, Italy
Novartis Investigative Site
Yokohama, Japan
Novartis Investigative Site
Shinjuku-ku, Japan
Novartis Investigative Site
Osaka, Japan
Novartis Investigative Site
Utrecht, Netherlands
Novartis Investigative Site
Wroclaw, Poland
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Saint Petersburg, Russia
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Khon Kaen, Thailand
Novartis Investigative Site
Bangkok, Thailand
Novartis Investigative Site
Chiang Mai, Thailand
Novartis Investigative Site
Istanbul, Turkey (Türkiye)
Novartis Investigative Site
Bursa, Turkey (Türkiye)
Trial contact
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.