Actively Recruiting
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
Eligibility Criteria
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.
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
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
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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