Asciminib Roll-over Study
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
3 other identifiers
interventional
347
29 countries
84
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2022
Longer than P75 for phase_4
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2021
CompletedFirst Posted
Study publicly available on registry
May 7, 2021
CompletedStudy Start
First participant enrolled
August 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2030
March 6, 2026
March 1, 2026
8 years
May 4, 2021
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Percentage of participants with clinical benefit as assessed by Investigator
8 years
Study Arms (11)
Asciminib single agent group
EXPERIMENTALParticipants 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
Bosutinib single agent group
OTHERParticipants with CML-CP, from Novartis sponsored asciminib study CABL001A2301, that were receiving bosutinib
Bosutinib-Asciminib switch group
EXPERIMENTALParticipants 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
Asciminib in combination with imatinib group
EXPERIMENTALParticipants with CML from Novartis sponsored asciminib studies CABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib
Asciminib in combination with nilotinib group
EXPERIMENTALParticipants with CML or ALL from Novartis sponsored asciminib studies CABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib
Imatinib single agent group
OTHERParticipants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 that were receiving imatinib
Nilotinib single agent group
OTHERParticipants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 and CABL001J12302 that were receiving nilotinib
Asciminib in combination with dasatinib group
EXPERIMENTALParticipants with CML from Novartis sponsored study CABL001X2101 that were receiving asciminib with dasatinib
Dasatinib single agent group
OTHERParticipant with CML-CP , from Novartis sponsored asciminib study CABL001A2202, CABL001J12301, that were receiving Dasatinib.
Dasatinib-Asciminib switch group
EXPERIMENTALParticipants 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
Asciminib single agent formulation for Pediatric
EXPERIMENTALParticipants with CML, from Novartis sponsored asciminib studies, including but not limited to CABL001I12201 study, that were receiving asciminib
Interventions
Taken orally, once daily, in the morning with low-fat meal
Taken orally, twice daily (BID) or once daily (QD), in fasting state
Taken orally, twice daily, on an empty stomach
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.
Eligibility Criteria
You may qualify if:
- 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 may not qualify if:
- 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.
- Applicable for participants on bosutinib treatment at the end of the CABL001A2301 and on other TKIs for CABL001A2202 study that switch to asciminib treatment:
- Asymptomatic (grade 2) pancreatitis if not resolved within 28 days
- QTcF\>480msec 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (84)
Michigan Med University of Michigan
Ann Arbor, Michigan, 48109 5271, United States
Memorial Sloan Kettering
New York, New York, 10017, United States
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
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, 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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Seoul, Korea, 03080, South Korea
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Busan, 49201, South Korea
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Jeollanam, 519763, 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 District, 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
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
May 4, 2021
First Posted
May 7, 2021
Study Start
August 30, 2022
Primary Completion (Estimated)
August 29, 2030
Study Completion (Estimated)
August 30, 2030
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
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