Novartis Investigative Site 91054 Erlangen (Bayern) GermanyRekrutierend» Google-MapsNovartis Investigative Site 45147 Essen (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsNovartis Investigative Site 20246 Hamburg (Hamburg) GermanyRekrutierend» Google-Maps
Dana Farber Cancer Institute Dept.of DFCI 02215 Boston United StatesRekrutierend» Google-Maps Ansprechpartner: Taylor Sorrentino E-Mail: taylor_sorrentino@dfci.harvard.edu» Ansprechpartner anzeigenColumbia University Medical Center- New York Presbyterian Herbert Irving Cancer Center 10032 New York United StatesRekrutierend» Google-Maps Ansprechpartner:
Phone: 212-305-9770» Ansprechpartner anzeigenCinn Children Hosp Medical Center 45229-3039 Cincinnati United StatesRekrutierend» Google-Maps Ansprechpartner: Jenni Ho Phone: 800-344-2462 E-Mail: jenni.ho@cchmc.org» Ansprechpartner anzeigenUniversity of Utah Primary Childrens Hospital 84132 Salt Lake City United StatesRekrutierend» Google-Maps Ansprechpartner: Keeley Best Phone: 801-213-3599 E-Mail: Keeley.Best@imail2.org» Ansprechpartner anzeigenNovartis Investigative Site 310005 Hangzhou ChinaRekrutierend» Google-MapsNovartis Investigative Site 100044 Beijing ChinaRekrutierend» Google-MapsNovartis Investigative Site 200127 Shanghai ChinaRekrutierend» Google-MapsNovartis Investigative Site 300020 Tianjin ChinaRekrutierend» Google-MapsNovartis Investigative Site 33076 Bordeaux Cedex FranceRekrutierend» Google-MapsNovartis Investigative Site 59000 Lille FranceRekrutierend» Google-MapsNovartis Investigative Site 75019 Paris FranceRekrutierend» Google-MapsNovartis Investigative Site 86021 Poitiers FranceRekrutierend» Google-MapsNovartis Investigative Site 115 27 Athens GreeceRekrutierend» Google-MapsNovartis Investigative Site 1094 Budapest HungaryRekrutierend» Google-MapsNovartis Investigative Site 16147 Genova ItalyRekrutierend» Google-MapsNovartis Investigative Site 20900 Monza ItalyRekrutierend» Google-MapsNovartis Investigative Site 10126 Torino ItalyRekrutierend» Google-MapsNovartis Investigative Site 232-8555 Yokohama-city JapanRekrutierend» Google-MapsNovartis Investigative Site 160 8582 Shinjuku-ku JapanRekrutierend» Google-MapsNovartis Investigative Site 534-0021 Osaka JapanRekrutierend» Google-MapsNovartis Investigative Site 05505 Seoul Korea, Republic ofRekrutierend» Google-MapsNovartis Investigative Site 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsNovartis Investigative Site 3584 Utrecht NetherlandsRekrutierend» Google-MapsNovartis Investigative Site 50367 Wrocław PolandRekrutierend» Google-MapsNovartis Investigative Site 117198 Moscow Russian FederationRekrutierend» Google-MapsNovartis Investigative Site 197022 Saint Petersburg Russian FederationRekrutierend» Google-MapsNovartis Investigative Site 50200 Muang ThailandRekrutierend» Google-MapsNovartis Investigative Site 10400 Bangkok ThailandRekrutierend» Google-MapsNovartis Investigative Site 40000 Khon Kaen ThailandRekrutierend» Google-MapsNovartis Investigative Site 16059 Bursa TurkeyRekrutierend» Google-MapsNovartis Investigative Site 34093 Istanbul TurkeyRekrutierend» Google-Maps
1. Primary Pharmacokinetic (PK) parameter: AUClast (Time Frame - 52 weeks): Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).
2. Primary PK parameter: AUCtau (Time Frame - 52 weeks): Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).
3. Secondary PK parameter: Cmax (Time Frame - 52 weeks): Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).
4. Secondary PK parameter: Tmax (Time Frame - 52 weeks): Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).
5. Secondary PK parameter: Ctrough (Time Frame - 52 weeks): Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).
Secondary outcome:
1. Hematologic responses (Time Frame - 52 weeks): Complete hematological response will be defined as all of the following present for ≥ 4 weeks:
WBC count < 10 x 10^9/L
Platelet count < 450 x 10^9/L
Basophils < 5%
No blasts and promyelocytes in peripheral blood
Myelocytes + metamyelocytes < 5% in peripheral blood
No evidence of extramedullary disease, including spleen and liver
2. Molecular responses (Time Frame - 52 weeks): To assess pharmacodynamic markers of asciminib's anti-leukemic activity. Molecular response will be assessed by Breakpoint Cluster Region gene-Abelson proto-oncogene (BCR-ABL) 1 level.
3. Questionnaire on acceptability and palatability after first dose, 4 and 52 weeks (Time Frame - after first dose at Week 1 Day 1, 4 weeks, 52 weeks): To assess acceptability and palatability of the pediatric formulation