In plain English
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Official title
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
About this study
This is an open-label, multi-center, global roll-over study designed to assess long term safety and provide continued treatment to participants who have previously participated in an asciminib Novartis sponsored study and who, in the opinion of the investigator, would benefit from continued treatment as in their parent study but are unable to access this treatment outside of the clinical study.
Eligibility criteria
Key Inclusion Criteria:
1. 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.
2. 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.
Key Exclusion Criteria:
1. Participant has been discontinued from parent study treatment.
2. Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.
3. Participant's ongoing treatment is currently approved and reimbursed at country level.
4. Pregnant or nursing (lactating) women.
5. Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.
6. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.
7. 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
Other protocol-defined Inclusion/Exclusion criteria may apply.
Study design
Enrollment target: 347 participants
Allocation: non_randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2022-08-30
Estimated completion: 2030-08-30
Last updated: 2026-03-06
Interventions
Drug: Asciminib single agentDrug: ImatinibDrug: NilotinibDrug: BosutinibDrug: DasatinibDrug: Asciminib single agent pediatric formulation
Primary outcomes
- • Number of participants with adverse events (AEs) and serious adverse events (SAEs) (8 years)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · 1-888-669-6682
ContactNovartis Pharmaceuticals · contact · +41613241111
InvestigatorNovartis Pharmaceuticals · study_director, Novartis Pharmaceuticals
All locations (84)
Michigan Med University of MichiganRecruiting
Ann Arbor, Michigan, United States
Memorial Sloan KetteringRecruiting
New York, New York, United States
Oregon Health Sciences UniversityActive Not Recruiting
Portland, Oregon, United States
Texas OncologyRecruiting
Dallas, Texas, United States
Uni Of TX MD Anderson Cancer CntrRecruiting
Houston, Texas, United States
Novartis Investigative SiteRecruiting
CABA, Buenos Aires, Argentina
Novartis Investigative SiteRecruiting
Capital Federal, Argentina
Novartis Investigative SiteRecruiting
Graz, Austria
Novartis Investigative SiteRecruiting
Vienna, Austria
Novartis Investigative SiteRecruiting
Rio de Janeiro, Rio de Janeiro, Brazil
Novartis Investigative SiteRecruiting
São Paulo, São Paulo, Brazil
Novartis Investigative SiteRecruiting
São Paulo, São Paulo, Brazil
Novartis Investigative SiteRecruiting
Varna, Bulgaria
Novartis Investigative SiteRecruiting
Montreal, Quebec, Canada
Novartis Investigative SiteRecruiting
Chongqing, Chongqing Municipality, China
Novartis Investigative SiteRecruiting
Guangzhou, Guangdong, China
Novartis Investigative SiteRecruiting
Zhengzhou, Henan, China
Novartis Investigative SiteRecruiting
Wuhan, Hubei, China
Novartis Investigative SiteRecruiting
Changchun, Jilin, China
Novartis Investigative SiteRecruiting
Xian, Shanxi, China
Novartis Investigative SiteCompleted
Chengdu, Sichuan, China
Novartis Investigative SiteActive Not Recruiting
Beijing, China
Novartis Investigative SiteRecruiting
Beijing, China
Novartis Investigative SiteActive Not Recruiting
Shanghai, China
Novartis Investigative SiteRecruiting
Shenyang, China
Novartis Investigative SiteRecruiting
Tianjin, China
Novartis Investigative SiteRecruiting
Ostrava, Poruba, Czechia
Novartis Investigative SiteRecruiting
Brno, Czechia
Novartis Investigative SiteCompleted
Copenhagen, Denmark
Novartis Investigative SiteRecruiting
Bordeaux, France
Novartis Investigative SiteRecruiting
Lyon, France
Novartis Investigative SiteRecruiting
Marseille, France
Novartis Investigative SiteRecruiting
Nantes, France
Novartis Investigative SiteRecruiting
Paris, France
Novartis Investigative SiteRecruiting
Vandœuvre-lès-Nancy, France
Novartis Investigative SiteRecruiting
Frankfurt am Main, Hesse, Germany
Novartis Investigative SiteRecruiting
Jena, Thuringia, Germany
Novartis Investigative SiteRecruiting
Berlin, Germany
Novartis Investigative SiteRecruiting
Kiel, Germany
Novartis Investigative SiteRecruiting
Milan, MI, Italy
Novartis Investigative SiteRecruiting
Roma, RM, Italy
Novartis Investigative SiteCompleted
Naples, Italy
Novartis Investigative SiteActive Not Recruiting
Kobe, Japan
Novartis Investigative SiteCompleted
Beirut, Lebanon
Novartis Investigative SiteRecruiting
George Town, Pulau Pinang, Malaysia
Novartis Investigative SiteRecruiting
Johor Bahru, Malaysia
Novartis Investigative SiteRecruiting
Kuala Selangor, Malaysia
Novartis Investigative SiteRecruiting
Monterrey, Nuevo León, Mexico
Novartis Investigative SiteRecruiting
Khoudh, Oman
Novartis Investigative SiteRecruiting
Katowice, Poland
Novartis Investigative SiteCompleted
Krakow, Poland
Novartis Investigative SiteRecruiting
Warsaw, Poland
Novartis Investigative SiteCompleted
Wroclaw, Poland
Novartis Investigative SiteActive Not Recruiting
Lisbon, Portugal
Novartis Investigative SiteRecruiting
Porto, Portugal
Novartis Investigative SiteRecruiting
Timișoara, Romania
Novartis Investigative SiteActive Not Recruiting
Moscow, Russia
Novartis Investigative SiteActive Not Recruiting
Moscow, Russia
Novartis Investigative SiteRecruiting
Saint Petersburg, Russia
Novartis Investigative SiteRecruiting
Saint Petersburg, Russia
Novartis Investigative SiteCompleted
Riyadh, Saudi Arabia
Novartis Investigative SiteActive Not Recruiting
Singapore, Singapore
Novartis Investigative SiteActive Not Recruiting
Uijeongbu-si, Gyeonggi-do, South Korea
Novartis Investigative SiteRecruiting
Seoul, Korea, South Korea
Novartis Investigative SiteCompleted
Busan, South Korea
Novartis Investigative SiteCompleted
Jeollanam, South Korea
Novartis Investigative SiteRecruiting
Santiago Compostela, A Coruna, Spain
Novartis Investigative SiteRecruiting
Badalona, Barcelona, Spain
Novartis Investigative SiteRecruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative SiteRecruiting
Bilbao, Bizkaia, Spain
Novartis Investigative SiteRecruiting
Santa Cruz, Santa Cruz De Tenerife, Spain
Novartis Investigative SiteRecruiting
Barcelona, Spain
Novartis Investigative SiteRecruiting
Barcelona, Spain
Novartis Investigative SiteRecruiting
Madrid, Spain
Novartis Investigative SiteCompleted
Madrid, Spain
Novartis Investigative SiteRecruiting
Madrid, Spain
Novartis Investigative SiteRecruiting
Seville, Spain
Novartis Investigative SiteRecruiting
Valencia, Spain
Novartis Investigative SiteActive Not Recruiting
Taoyuan District, Taiwan
Novartis Investigative SiteRecruiting
Samsun, Atakum, Turkey (Türkiye)
Novartis Investigative SiteRecruiting
London, United Kingdom
Novartis Investigative SiteRecruiting
Oxford, United Kingdom
Novartis Investigative SiteRecruiting
Hanoi, Vietnam
Novartis Investigative SiteRecruiting
Ho Chi Minh City, Vietnam