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A Multi-center, Open-label Study to Determine the Dose and Safety of Oral Asciminib in Pediatric Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia in Chronic Phase (Ph+ CML-CP), Previously Treated With One or More Tyrosine Kinase Inhibitors
Sponsor study identifier
Secondary identifiers
OTHER · EU CTIS
NIH
interventional
34
14 countries
39
Study Start
December 27, 2021
Actual (reported)Primary Completion
September 2, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 18, 2021
Actual (reported)June 14, 2021
Actual (reported)December 27, 2021
Actual (reported)September 2, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Pharmacokinetic (PK) parameter: AUClast
Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).
52 weeks
Primary PK parameter: AUCtau
Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).
52 weeks
Secondary PK parameter: Cmax
Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).
52 weeks
This arm consists of 2 groups: * The pediatric formulation group where the dose is based on body weight (1.3mg/kg BID or 2.6 mg/kg QD) * The adult formulation group where participants will receive a flat dose of 40mg BID
Asciminib Pediatric formulation group: 1 mg film-coated granules in a size 0 capsule will be supplied, taken orally (capsules are a container for the granules and are not ingested): 10 mg (10x 1 mg film-coated granules in capsule) 15 mg (15x 1 mg film-coated granules in capsule) 30 mg (30x 1 mg film-coated granules in capsule)
Indiana UH Riley H for CIU
Indianapolis, Indiana, 46202-5167, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505, United States
Novartis Pharmaceuticals
Novartis Pharmaceuticals
First Submitted
May 18, 2021
First Posted
June 14, 2021
Study Start
December 27, 2021
Actual (reported)Primary Completion
September 2, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Secondary PK parameter: Tmax
Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).
52 weeks
Secondary PK parameter: Ctrough
Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).
52 weeks
Hematologic responses
52 weeks
Molecular responses
52 weeks
Questionnaire on acceptability and palatability after first dose, 4 and 52 weeks
after first dose at Week 1 Day 1, 4 weeks, 52 weeks
Asciminib Adult formulation group: 40 mg tablets BID, taken orally. 20 mg tablets BID, taken orally.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Columbia University Medical Center New York Presbyterian
New York, New York, 10032, United States
Cinn Children Hosp Medical Center
Cincinnati, Ohio, 45229-3039, United States
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4399, United States
Uni Of Texas MD Anderson Cancer Ctr
Houston, Texas, 77024, United States
University Of Utah
Salt Lake City, Utah, 84132, United States
Novartis Investigative Site
Hangzhou, Zhejiang, 310052, China
Novartis Investigative Site
Beijing, 100044, China
Novartis Investigative Site
Shanghai, 200127, China
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Tianjin, 300020, China
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Bordeaux, 33076, France
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Lille, 59000, France
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Paris, 75019, France
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Poitiers, 86021, France
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Erlangen, 91054, Germany
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Essen, 45147, Germany
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Hamburg, 20246, Germany
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Athens, 115 27, Greece
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Budapest, 1083, Hungary
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Genova, GE, 16147, Italy
Novartis Investigative Site
Monza, MB, 20900, Italy
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Roma, RM, 00165, Italy
Novartis Investigative Site
Torino, TO, 10126, Italy
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Yokohama, Kanagawa, 2328555, Japan
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Shinjuku-ku, Tokyo, 1608582, Japan
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Osaka, 5340021, Japan
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Utrecht, 3584 CS, Netherlands
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Wroclaw, 50-367, Poland
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Moscow, 117198, Russia
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Saint Petersburg, 197022, Russia
Novartis Investigative Site
Seoul, 03080, South Korea
Novartis Investigative Site
Seoul, 05505, South Korea
Novartis Investigative Site
Khon Kaen, THA, 40002, Thailand
Novartis Investigative Site
Bangkok, 10400, Thailand
Novartis Investigative Site
Chiang Mai, 50200, Thailand
Novartis Investigative Site
Istanbul, Fatih, 34093, Turkey (Türkiye)
Novartis Investigative Site
Bursa, Nilufer, 16059, Turkey (Türkiye)
Study Completion
October 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 25, 2026
Record last verified: 2026-09
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
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