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An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment
Sponsor study identifier
Secondary identifiers
interventional
347
36 countries
92
Study Start
August 30, 2022
Actual (reported)Primary Completion
August 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 4, 2021
Actual (reported)May 7, 2021
Actual (reported)August 30, 2022
Actual (reported)August 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
All AEs and SAEs will be tabulated and listed for participants in the Safety Set by treatment group. From day of first administration of study treatment to 30 days after the last study treatment.
8 years
Percentage of participants with clinical benefit as assessed by Investigator
8 years
Participants with CML or ALL, from Novartis sponsored asciminib studies, including but not limited to CABL001A2301, CABL001A2302, CABL001X2101, CABL001A2202, CABL001AUS04 and CABL001AUS08 studies, that were receiving asciminib
Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301, that were receiving bosutinib
Taken orally, twice daily (BID) or once daily (QD), in fasting state
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
BOSUTINIB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordFormulated product
BOSUTINIB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordFormulated product
DASATINIB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
DASATINIB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
DASATINIB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
BOSUTINIB
Named ingredient: bosutinib
View registry recordBOSUTINIB
Named ingredient: bosutinib
View registry recordDASATINIB
Named ingredient: Dasatinib
View registry recordDASATINIB
Named ingredient: Dasatinib
View registry recordDASATINIB
Named ingredient: Dasatinib
View registry recordDASATINIB
Named ingredient: Dasatinib
View registry recordMichigan Med University of Michigan
Ann Arbor, Michigan, 48109 5271, United States
Memorial Sloan Kettering
New York, New York, 10017, United States
Novartis Pharmaceuticals
Novartis Pharmaceuticals
First Submitted
May 4, 2021
First Posted
May 7, 2021
Study Start
August 30, 2022
Actual (reported)Primary Completion
August 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301 that were receiving bosutinib treatment and switched to asciminib when entering this study or during the course of this study
Participants with CML from Novartis sponsored asciminib studies CABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib
Participants with CML or ALL from Novartis sponsored asciminib studies CABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib
Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 that were receiving imatinib
Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 and CABL001J12302 that were receiving nilotinib
Participants with CML from Novartis sponsored study CABL001X2101 that were receiving asciminib with dasatinib
Participant with CML-CP , from Novartis sponsored asciminib study CABL001A2202, CABL001J12301, that were receiving Dasatinib.
Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2202 that were receiving best available therapy (dasatinib) and switched to asciminib when entering this study or during the course of this study
Participants with CML, from Novartis sponsored asciminib studies, including but not limited to CABL001I12201 study, that were receiving asciminib
Taken orally, once daily, in the morning with low-fat meal
Taken orally, twice daily, on an empty stomach
Taken orally, once daily, with food
Taken orally, once daily in a fasted state, 1 or 2 hours before a meal
Pediatric participants receive a body weight adjusted dose of 1.3 mg/kg of pediatric film coated granules with food twice daily (b.i.d.) or 2.6 mg/kg once daily (q.d.) in the morning.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
TABLET
Formulated product
DASATINIB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordContact the study team to confirm eligibility.
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Texas Oncology
Dallas, Texas, 75251, United States
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, 77030, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Novartis Investigative Site
CABA, Buenos Aires, C1221ADC, Argentina
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Capital Federal, C1114AAN, Argentina
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Graz, 8036, Austria
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Vienna, 1140, Austria
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Rio de Janeiro, Rio de Janeiro, 20211-030, Brazil
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São Paulo, São Paulo, 05403 000, Brazil
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São Paulo, São Paulo, 08270-070, Brazil
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Varna, 9000, Bulgaria
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Montreal, Quebec, H1T 2M4, Canada
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Chongqing, Chongqing Municipality, 400010, China
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Guangzhou, Guangdong, 510515, China
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Zhengzhou, Henan, 450008, China
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Wuhan, Hubei, 430022, China
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Changchun, Jilin, 130021, China
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Xian, Shanxi, 710004, China
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Chengdu, Sichuan, 610041, China
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Beijing, 100044, China
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Beijing, 100730, China
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Shanghai, 200025, China
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Shenyang, 110004, China
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Tianjin, 300020, China
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Ostrava, Poruba, 708 52, Czechia
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Brno, 625 00, Czechia
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Copenhagen, DK-2100, Denmark
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Bordeaux, 33076, France
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Lyon, 69373, France
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Marseille, 13273, France
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Nantes, 44093, France
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Paris, 75475, France
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Vandœuvre-lès-Nancy, 54511, France
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Frankfurt am Main, Hesse, 60590, Germany
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Jena, Thuringia, 07740, Germany
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Berlin, 13353, Germany
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Kiel, 24116, Germany
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Milan, MI, 20162, Italy
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Roma, RM, 00161, Italy
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Naples, 80131, Italy
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Kobe, Hyōgo, 650-0017, Japan
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Beirut, 113-0236, Lebanon
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George Town, Pulau Pinang, 10450, Malaysia
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Johor Bahru, 80100, Malaysia
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Kuala Selangor, 68000, Malaysia
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Monterrey, Nuevo León, 64460, Mexico
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Khoudh, 123, Oman
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Katowice, 40-519, Poland
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Krakow, 30-688, Poland
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Warsaw, 00-791, Poland
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Wroclaw, 50 367, Poland
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Lisbon, 1099-023, Portugal
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Porto, 4200-072, Portugal
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Timișoara, 300079, Romania
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Moscow, 125167, Russia
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Moscow, 125284, Russia
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Saint Petersburg, 191024, Russia
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Saint Petersburg, 197341, Russia
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Riyadh, 11211, Saudi Arabia
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Singapore, 169608, Singapore
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Uijeongbu-si, Gyeonggi-do, 11759, South Korea
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Busan, 49201, South Korea
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Jeollanam, 519763, South Korea
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Seoul, 03080, South Korea
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Santiago Compostela, A Coruna, 15706, Spain
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Badalona, Barcelona, 08916, Spain
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L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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Bilbao, Bizkaia, 48013, Spain
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Santa Cruz, Santa Cruz De Tenerife, 38009, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Madrid, 28006, Spain
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Madrid, 28034, Spain
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Madrid, 28041, Spain
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Seville, 41009, Spain
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Valencia, 46026, Spain
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Taoyuan, 33305, Taiwan
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Samsun, Atakum, 55200, Turkey (Türkiye)
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London, W12 0HS, United Kingdom
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Oxford, OX3 7LE, United Kingdom
Novartis Investigative Site
Hanoi, 100000, Vietnam
Novartis Investigative Site
Ho Chi Minh City, 70000, Vietnam
Study Completion
August 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 6, 2026
Record last verified: 2026-07
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 review 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 availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study fields come from the primary record; confirmed relationships can use other sources. Selecting a record here changes its provenance and downloads, without replacing the displayed study fields.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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