Actively Recruiting

Phase 4
Age: 7Years - 100Years
All Genders
NCT04877522

Asciminib Roll-over Study

Led by Novartis Pharmaceuticals · Updated on 2026-05-11

347

Participants Needed

84

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment

CONDITIONS

Official Title

Asciminib Roll-over Study

Who Can Participate

Age: 7Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant with PH+ CML or PH+ ALL currently receiving treatment with asciminib (single agent or in combination with imatinib, nilotinib or dasatinib), imatinib, nilotinib or bosutinib alone within a Novartis-sponsored study and, in the opinion of the Investigator, would benefit from continued treatment.
  • Participant has demonstrated compliance on the parent study protocol and is willing and able to comply with scheduled visits, treatment plans and any other study procedures.
Not Eligible

You will not qualify if you...

  • Participant has been discontinued from parent study treatment.
  • Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.
  • Participant's ongoing treatment is currently approved and reimbursed at country level.
  • Pregnant or nursing (lactating) women.
  • Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.
  • Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.
  • For participants on bosutinib treatment at the end of the CABL001A2301 and on other TKIs for CABL001A2202 study who switch to asciminib treatment:
    • Asymptomatic (grade 2) pancreatitis if not resolved within 28 days
    • QTcF greater than 480 msec or inability to determine QTc interval
    • Any grade 3 or 4 toxicity not resolved to grade 2 or lower within 28 days before starting asciminib treatment
  • Other protocol-defined Inclusion/Exclusion criteria may apply.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 84 locations

1

Michigan Med University of Michigan

Ann Arbor, Michigan, United States, 48109 5271

Actively Recruiting

2

Memorial Sloan Kettering

New York, New York, United States, 10017

Actively Recruiting

3

Oregon Health Sciences University

Portland, Oregon, United States, 97239

Active, Not Recruiting

4

Texas Oncology

Dallas, Texas, United States, 75251

Actively Recruiting

5

Uni Of TX MD Anderson Cancer Cntr

Houston, Texas, United States, 77030

Actively Recruiting

6

Novartis Investigative Site

CABA, Buenos Aires, Argentina, C1221ADC

Actively Recruiting

7

Novartis Investigative Site

Capital Federal, Argentina, C1114AAN

Actively Recruiting

8

Novartis Investigative Site

Graz, Austria, 8036

Actively Recruiting

9

Novartis Investigative Site

Vienna, Austria, 1140

Actively Recruiting

10

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, Brazil, 20211-030

Completed

11

Novartis Investigative Site

São Paulo, São Paulo, Brazil, 05403 000

Completed

12

Novartis Investigative Site

São Paulo, São Paulo, Brazil, 08270-070

Completed

13

Novartis Investigative Site

Varna, Bulgaria, 9000

Actively Recruiting

14

Novartis Investigative Site

Montreal, Quebec, Canada, H1T 2M4

Actively Recruiting

15

Novartis Investigative Site

Chongqing, Chongqing Municipality, China, 400010

Actively Recruiting

16

Novartis Investigative Site

Guangzhou, Guangdong, China, 510515

Actively Recruiting

17

Novartis Investigative Site

Zhengzhou, Henan, China, 450008

Actively Recruiting

18

Novartis Investigative Site

Wuhan, Hubei, China, 430022

Actively Recruiting

19

Novartis Investigative Site

Changchun, Jilin, China, 130021

Actively Recruiting

20

Novartis Investigative Site

Xian, Shanxi, China, 710004

Actively Recruiting

21

Novartis Investigative Site

Chengdu, Sichuan, China, 610041

Completed

22

Novartis Investigative Site

Beijing, China, 100044

Active, Not Recruiting

23

Novartis Investigative Site

Beijing, China, 100730

Actively Recruiting

24

Novartis Investigative Site

Shanghai, China, 200025

Active, Not Recruiting

25

Novartis Investigative Site

Shenyang, China, 110004

Actively Recruiting

26

Novartis Investigative Site

Tianjin, China, 300020

Actively Recruiting

27

Novartis Investigative Site

Ostrava, Poruba, Czechia, 708 52

Actively Recruiting

28

Novartis Investigative Site

Brno, Czechia, 625 00

Actively Recruiting

29

Novartis Investigative Site

Copenhagen, Denmark, DK-2100

Completed

30

Novartis Investigative Site

Bordeaux, France, 33076

Actively Recruiting

31

Novartis Investigative Site

Lyon, France, 69373

Actively Recruiting

32

Novartis Investigative Site

Marseille, France, 13273

Actively Recruiting

33

Novartis Investigative Site

Nantes, France, 44093

Actively Recruiting

34

Novartis Investigative Site

Paris, France, 75475

Actively Recruiting

35

Novartis Investigative Site

Vandœuvre-lès-Nancy, France, 54511

Actively Recruiting

36

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany, 60590

Actively Recruiting

37

Novartis Investigative Site

Jena, Thuringia, Germany, 07740

Actively Recruiting

38

Novartis Investigative Site

Berlin, Germany, 13353

Actively Recruiting

39

Novartis Investigative Site

Kiel, Germany, 24116

Actively Recruiting

40

Novartis Investigative Site

Milan, MI, Italy, 20162

Actively Recruiting

41

Novartis Investigative Site

Roma, RM, Italy, 00161

Actively Recruiting

42

Novartis Investigative Site

Naples, Italy, 80131

Completed

43

Novartis Investigative Site

Kobe, Japan, 650-0017

Active, Not Recruiting

44

Novartis Investigative Site

Beirut, Lebanon, 113-0236

Completed

45

Novartis Investigative Site

George Town, Pulau Pinang, Malaysia, 10450

Actively Recruiting

46

Novartis Investigative Site

Johor Bahru, Malaysia, 80100

Actively Recruiting

47

Novartis Investigative Site

Kuala Selangor, Malaysia, 68000

Actively Recruiting

48

Novartis Investigative Site

Monterrey, Nuevo León, Mexico, 64460

Actively Recruiting

49

Novartis Investigative Site

Khoudh, Oman, 123

Actively Recruiting

50

Novartis Investigative Site

Katowice, Poland, 40-519

Actively Recruiting

51

Novartis Investigative Site

Krakow, Poland, 30-688

Completed

52

Novartis Investigative Site

Warsaw, Poland, 00-791

Actively Recruiting

53

Novartis Investigative Site

Wroclaw, Poland, 50 367

Completed

54

Novartis Investigative Site

Lisbon, Portugal, 1099-023

Active, Not Recruiting

55

Novartis Investigative Site

Porto, Portugal, 4200-072

Actively Recruiting

56

Novartis Investigative Site

Timișoara, Romania, 300079

Completed

57

Novartis Investigative Site

Moscow, Russia, 125167

Active, Not Recruiting

58

Novartis Investigative Site

Moscow, Russia, 125284

Active, Not Recruiting

59

Novartis Investigative Site

Saint Petersburg, Russia, 191024

Actively Recruiting

60

Novartis Investigative Site

Saint Petersburg, Russia, 197341

Actively Recruiting

61

Novartis Investigative Site

Riyadh, Saudi Arabia, 11211

Completed

62

Novartis Investigative Site

Singapore, Singapore, 169608

Active, Not Recruiting

63

Novartis Investigative Site

Uijeongbu-si, Gyeonggi-do, South Korea, 11759

Active, Not Recruiting

64

Novartis Investigative Site

Busan, South Korea, 49201

Completed

65

Novartis Investigative Site

Jeollanam, South Korea, 519763

Completed

66

Novartis Investigative Site

Seoul, South Korea, 03080

Actively Recruiting

67

Novartis Investigative Site

Santiago Compostela, A Coruna, Spain, 15706

Actively Recruiting

68

Novartis Investigative Site

Badalona, Barcelona, Spain, 08916

Actively Recruiting

69

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, Spain, 08907

Actively Recruiting

70

Novartis Investigative Site

Bilbao, Bizkaia, Spain, 48013

Actively Recruiting

71

Novartis Investigative Site

Santa Cruz, Santa Cruz De Tenerife, Spain, 38009

Actively Recruiting

72

Novartis Investigative Site

Barcelona, Spain, 08035

Actively Recruiting

73

Novartis Investigative Site

Barcelona, Spain, 08036

Completed

74

Novartis Investigative Site

Madrid, Spain, 28006

Actively Recruiting

75

Novartis Investigative Site

Madrid, Spain, 28034

Completed

76

Novartis Investigative Site

Madrid, Spain, 28041

Actively Recruiting

77

Novartis Investigative Site

Seville, Spain, 41009

Actively Recruiting

78

Novartis Investigative Site

Valencia, Spain, 46026

Actively Recruiting

79

Novartis Investigative Site

Taoyuan, Taiwan, 33305

Active, Not Recruiting

80

Novartis Investigative Site

Samsun, Atakum, Turkey (Türkiye), 55200

Actively Recruiting

81

Novartis Investigative Site

London, United Kingdom, W12 0HS

Actively Recruiting

82

Novartis Investigative Site

Oxford, United Kingdom, OX3 7LE

Actively Recruiting

83

Novartis Investigative Site

Hanoi, Vietnam, 100000

Actively Recruiting

84

Novartis Investigative Site

Ho Chi Minh City, Vietnam, 70000

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

11

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Asciminib Roll-over Study | DecenTrialz