Study Description
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
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 the parent study, or from switching to asciminib (if they were on bosutinib in the parent study), but are unable to access this treatment outside of the clinical study.
Interventions
Asciminib
Asciminib single agent
Bosutinib
Dasatinib
Imatinib
Nilotinib
Eligibility Criteria
Key Inclusion Criteria:
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.
Key Exclusion Criteria:
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 only for participants on bosutinib treatment that switch to asciminib treatment at enrollment:
Asymptomatic pancreatitis
abnormal ECG
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 Location
Novartis Investigative Site
Recruiting
Caba,Buenos Aires,C1221ADC,Argentina
Novartis Investigative Site
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Wien,1140,Austria
Novartis Investigative Site
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Sao Paulo,SP,05403 000,Brazil
Novartis Investigative Site
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Sao Paulo,SP,08270-070,Brazil
Novartis Investigative Site
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Rio de Janeiro,RJ,20211-030,Brazil
Novartis Investigative Site
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Varna,9000,Bulgaria
Novartis Investigative Site
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Montreal,Quebec,H1T 2M4,Canada
Novartis Investigative Site
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Ostrava,Poruba,708 52,Czech Republic
Novartis Investigative Site
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Brno-Bohunice,639 00,Czech Republic
Novartis Investigative Site
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Copenhagen,DK-2100,Denmark
Novartis Investigative Site
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Marseille,13273,France
Novartis Investigative Site
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Vandoeuvre les Nancy,54511,France
Novartis Investigative Site
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Paris 10,75475,France
Novartis Investigative Site
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Bordeaux,33076,France
Novartis Investigative Site
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Frankfurt,60590,Germany
Novartis Investigative Site
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Berlin,13353,Germany
Novartis Investigative Site
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Jena,07740,Germany
Novartis Investigative Site
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Napoli,80132,Italy
Novartis Investigative Site
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Milano,MI,20162,Italy
Novartis Investigative Site
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Roma,RM,00161,Italy
Novartis Investigative Site
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Monterrey,Nuevo Leon,64460,Mexico
Novartis Investigative Site
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Warszawa,02 776,Poland
Novartis Investigative Site
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Lisboa,1099 023,Portugal
Novartis Investigative Site
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Porto,4200-072,Portugal
Novartis Investigative Site
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Timisoara,300079,Romania
Novartis Investigative Site
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Saint Petersburg,197341,Russian Federation
Novartis Investigative Site
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Moscow,125167,Russian Federation
Novartis Investigative Site
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Moscow,125284,Russian Federation
Novartis Investigative Site
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St Petersburg,191024,Russian Federation
Novartis Investigative Site
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Barcelona,Catalunya,08036,Spain
Novartis Investigative Site
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Valencia,46026,Spain
Novartis Investigative Site
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Hospitalet de LLobregat,Catalunya,08907,Spain
Novartis Investigative Site
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Bilbao,Pais Vasco,48013,Spain
Novartis Investigative Site
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Sevilla,Andalucia,41009,Spain
Novartis Investigative Site
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Madrid,28006,Spain
Novartis Investigative Site
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Madrid,28034,Spain
Novartis Investigative Site
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Samsun,55139,Turkey
Novartis Investigative Site
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Oxford,OX3 7LJ,United Kingdom
Uni of TX MD Anderson Cancer Cntr
Recruiting
Houston,(713-792-2921) -- Koji Sasaki,77030 - Texas,United States
Memorial Sloan Kettering
Recruiting
New York,Dalisa Espinosa (646-497-9068) email: [email protected] -- Michael Mauro,10017 - New York,United States
Michigan Med University of Michigan .
Recruiting
Ann Arbor,Moshe Talpaz,48109 5271 - Michigan,United States
Worldwide Contacts
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