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 their parent study but are unable to access this treatment outside of the clinical study.
Interventions
Asciminib single agent
Bosutinib
Dasatinib
Imatinib
Nilotinib
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.
Novartis Investigative Site
Recruiting
Wien,1140,Austria
Novartis Investigative Site
Recruiting
Sao Paulo,SP,08270-070,Brazil
Novartis Investigative Site
Recruiting
Rio de Janeiro,RJ,20211-030,Brazil
Novartis Investigative Site
Recruiting
Sao Paulo,SP,05403 000,Brazil
Novartis Investigative Site
Recruiting
Varna,9000,Bulgaria
Novartis Investigative Site
Recruiting
Montreal,Quebec,H1t 2m4,Canada
Novartis Investigative Site
Recruiting
Tianjin,300020,China
Novartis Investigative Site
Recruiting
Chang Chun,Jilin,130021,China
Novartis Investigative Site
Recruiting
Xian,Shanxi,710004,China
Novartis Investigative Site
Recruiting
Chengdu,Sichuan,610041,China
Novartis Investigative Site
Recruiting
Chongqing,Chongqing,400010,China
Novartis Investigative Site
Recruiting
Beijing,100730,China
Novartis Investigative Site
Recruiting
Guangzhou,Guangdong,510515,China
Novartis Investigative Site
Recruiting
Shanghai,200025,China
Novartis Investigative Site
Recruiting
Zhengzhou,Henan,450008,China
Novartis Investigative Site
Recruiting
Shenyang,110004,China
Novartis Investigative Site
Recruiting
Wuhan,Hubei,430022,China
Novartis Investigative Site
Recruiting
Ostrava,Poruba,708 52,Czechia
Novartis Investigative Site
Recruiting
Brno Bohunice,625 00,Czechia
Novartis Investigative Site
Recruiting
Copenhagen,Dk-2100,Denmark
Novartis Investigative Site
Recruiting
Paris 10,75475,France
Novartis Investigative Site
Recruiting
Vandoeuvre Les Nancy,54511,France
Novartis Investigative Site
Recruiting
Bordeaux,33076,France
Novartis Investigative Site
Recruiting
Marseille,13273,France
Novartis Investigative Site
Recruiting
Berlin,13353,Germany
Novartis Investigative Site
Recruiting
Frankfurt,60590,Germany
Novartis Investigative Site
Recruiting
Jena,07740,Germany
Novartis Investigative Site
Recruiting
Kiel,24116,Germany
Novartis Investigative Site
Recruiting
Napoli,80132,Italy
Novartis Investigative Site
Recruiting
Milano,MI,20162,Italy
Novartis Investigative Site
Recruiting
Roma,RM,00161,Italy
Novartis Investigative Site
Recruiting
Uijeongbu si,Gyeonggi Do,11759,Korea, Republic of
Novartis Investigative Site
Recruiting
Selangor,68000,Malaysia
Novartis Investigative Site
Recruiting
Monterrey,Nuevo Leon,64460,Mexico
Novartis Investigative Site
Recruiting
Katowice,40-519,Poland
Novartis Investigative Site
Recruiting
Warszawa,00-791,Poland
Novartis Investigative Site
Recruiting
Timisoara,300079,Romania
Novartis Investigative Site
Recruiting
Saint Petersburg,191024,Russian Federation
Novartis Investigative Site
Recruiting
Saint Petersburg,197341,Russian Federation
Novartis Investigative Site
Recruiting
Sevilla,Andalucia,41009,Spain
Novartis Investigative Site
Recruiting
Barcelona,Catalunya,08036,Spain
Novartis Investigative Site
Recruiting
Hospitalet de LLobregat,Catalunya,08907,Spain
Novartis Investigative Site
Recruiting
Bilbao,Pais Vasco,48013,Spain
Novartis Investigative Site
Recruiting
Madrid,28041,Spain
Novartis Investigative Site
Recruiting
Madrid,28006,Spain
Novartis Investigative Site
Recruiting
Santa Cruz de Tenerife,38009,Spain
Novartis Investigative Site
Recruiting
Madrid,28034,Spain
Novartis Investigative Site
Recruiting
Valencia,46026,Spain
Novartis Investigative Site
Recruiting
Samsun,55139,Turkey
Novartis Investigative Site
Recruiting
London,W12 0hs,United Kingdom
Novartis Investigative Site
Recruiting
Oxford,Ox3 7le,United Kingdom
Memorial Sloan Kettering
Recruiting
New York,New York,10017,United States
Michael Mauro
Uni Of TX MD Anderson Cancer Cntr
Recruiting
Houston,Texas,77030,United States
Koji Sasaki
Michigan Med University of Michigan
Recruiting
Ann Arbor,Michigan,48109 5271,United States
Brittany Williams
Moshe Talpaz
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.