Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

December 27, 2021

Primary Completion Date

June 30, 2026

Study Completion Date

November 1, 2031

Conditions
Myeloid Leukemia, Philadelphia Positive
Interventions
DRUG

Asciminib Pediatric formulation group

"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) 20 mg (20x 1 mg film-coated granules in capsule) 30 mg (30x 1 mg film-coated granules in capsule)"

DRUG

Asciminib Adult formulation group

"Asciminib Adult formulation group:~40 mg tablets BID, taken orally. 20 mg tablets BID, taken orally."

Trial Locations (40)

10032

RECRUITING

Columbia University Medical Center New York Presbyterian, New York

10126

RECRUITING

Novartis Investigative Site, Torino

10400

RECRUITING

Novartis Investigative Site, Bangkok

16059

RECRUITING

Novartis Investigative Site, Bursa

16147

RECRUITING

Novartis Investigative Site, Genova

20246

RECRUITING

Novartis Investigative Site, Hamburg

20900

RECRUITING

Novartis Investigative Site, Monza

33076

RECRUITING

Novartis Investigative Site, Bordeaux

34093

RECRUITING

Novartis Investigative Site, Istanbul

40002

RECRUITING

Novartis Investigative Site, Khon Kaen

45147

RECRUITING

Novartis Investigative Site, Essen

50200

RECRUITING

Novartis Investigative Site, Chiang Mai

50367

RECRUITING

Novartis Investigative Site, Wroclaw

59000

RECRUITING

Novartis Investigative Site, Lille

75019

RECRUITING

Novartis Investigative Site, Paris

77024

RECRUITING

Uni Of Texas MD Anderson Cancer Ctr, Houston

84132

RECRUITING

University Of Utah, Salt Lake City

86021

RECRUITING

Novartis Investigative Site, Poitiers

91054

RECRUITING

Novartis Investigative Site, Erlangen

100044

RECRUITING

Novartis Investigative Site, Beijing

117198

RECRUITING

Novartis Investigative Site, Moscow

197022

RECRUITING

Novartis Investigative Site, Saint Petersburg

200127

RECRUITING

Novartis Investigative Site, Shanghai

300020

RECRUITING

Novartis Investigative Site, Tianjin

310052

RECRUITING

Novartis Investigative Site, Hangzhou

46202-5167

RECRUITING

Indiana UH Riley H for CIU, Indianapolis

02215

RECRUITING

Dana Farber Cancer Institute, Boston

RECRUITING

Dana Farber Cancer Institute, Boston

39216-4505

RECRUITING

University of Mississippi Medical Center, Jackson

45229-3039

RECRUITING

Cinn Children Hosp Medical Center, Cincinnati

19104 4399

RECRUITING

Childrens Hospital of Philadelphia, Philadelphia

115 27

RECRUITING

Novartis Investigative Site, Athens

H-1083

RECRUITING

Novartis Investigative Site, Budapest

00165

RECRUITING

Novartis Investigative Site, Roma

232-8555

RECRUITING

Novartis Investigative Site, Yokohama

160 8582

RECRUITING

Novartis Investigative Site, Shinjuku-ku

534-0021

RECRUITING

Novartis Investigative Site, Osaka

3584 CS

RECRUITING

Novartis Investigative Site, Utrecht

03080

RECRUITING

Novartis Investigative Site, Seoul

05505

RECRUITING

Novartis Investigative Site, Seoul

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY