Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

PHASE2CompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

November 22, 2018

Primary Completion Date

November 8, 2021

Study Completion Date

February 26, 2025

Conditions
CMLChronic Myelogenous LeukemiaLeukemia, Myeloid ChronicHematologic Diseases
Interventions
DRUG

Asciminib add-on

Asciminib 60 mg or 40 mg taken orally once daily.

DRUG

Imatinib

Imatinib 400 mg taken orally once daily

DRUG

Nilotinib

Nilotinib 300 mg taken orally twice daily (total daily dose of 600 mg)

Trial Locations (30)

1140

Novartis Investigative Site, Vienna

11759

Novartis Investigative Site, Uijeongbu-si

20162

Novartis Investigative Site, Milan

21205

Sidney Kimmel Comprehensive Cancer Center, Baltimore

28034

Novartis Investigative Site, Madrid

30912

Georgia Regents University, Augusta

33076

Novartis Investigative Site, Bordeaux

33305

Novartis Investigative Site, Taoyuan District

41009

Novartis Investigative Site, Seville

46026

Novartis Investigative Site, Valencia

50006

Novartis Investigative Site, Changhua

125167

Novartis Investigative Site, Moscow

125284

Novartis Investigative Site, Moscow

191024

Novartis Investigative Site, Saint Petersburg

197341

Novartis Investigative Site, Saint Petersburg

H1T 2M4

Novartis Investigative Site, Montreal

625 00

Novartis Investigative Site, Brno

DK-2100

Novartis Investigative Site, Copenhagen

01307

Novartis Investigative Site, Dresden

00161

Novartis Investigative Site, Roma

31 531

Novartis Investigative Site, Krakow

00-791

Novartis Investigative Site, Warsaw

50 367

Novartis Investigative Site, Wroclaw

1099-023

Novartis Investigative Site, Lisbon

4200-072

Novartis Investigative Site, Porto

06591

Novartis Investigative Site, Seoul

08916

Novartis Investigative Site, Badalona

CH63 4JY

Novartis Investigative Site, Liverpool

W12 0HS

Novartis Investigative Site, London

OX3 7LE

Novartis Investigative Site, Oxford

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY