Phase
Condition
Leukemia
Chronic Myeloid Leukemia
Treatment
Nilotinib
Asciminib
Bosutinib
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 opinionof the Investigator, would benefit from continued treatment.
Participant has demonstrated compliance on the parent study protocol and is willingand able to comply with scheduled visits, treatment plans and any other studyprocedures.
Exclusion
Key Exclusion Criteria:
Participant has been discontinued from parent study treatment.
Participant currently has unresolved toxicities reported as possibly related tostudy treatment in the parent study.
Participant's ongoing treatment is currently approved and reimbursed at countrylevel.
Pregnant or nursing (lactating) women.
Women of child-bearing potential, unless they are using highly effective methods ofcontraception and willing to continue while taking study treatment.
Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinibunwilling to follow the relevant contraception requirements in the local prescribinginformation.
Applicable for participants on bosutinib treatment at the end of the CABL001A2301and 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 daysbefore starting asciminib treatment
Other protocol-defined Inclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Caba, Buenos Aires C1221ADC
ArgentinaSite Not Available
Novartis Investigative Site
Graz, 8036
AustriaActive - Recruiting
Novartis Investigative Site
Wien, 1140
AustriaActive - Recruiting
Novartis Investigative Site
Rio de Janeiro, RJ 20211-030
BrazilActive - Recruiting
Novartis Investigative Site
Sao Paulo, SP 08270-070
BrazilActive - Recruiting
Novartis Investigative Site
Varna, 9000
BulgariaActive - Recruiting
Novartis Investigative Site
Montreal, Quebec H1T 2M4
CanadaActive - Recruiting
Novartis Investigative Site
Chongqing, Chongqing 400010
ChinaActive - Recruiting
Novartis Investigative Site
Guangzhou, Guangdong 510515
ChinaActive - Recruiting
Novartis Investigative Site
Zhengzhou, Henan 450008
ChinaActive - Recruiting
Novartis Investigative Site
Wuhan, Hubei 430022
ChinaActive - Recruiting
Novartis Investigative Site
Chang Chun, Jilin 130021
ChinaActive - Recruiting
Novartis Investigative Site
Xian, Shanxi 710004
ChinaActive - Recruiting
Novartis Investigative Site
Chengdu, Sichuan 610041
ChinaActive - Recruiting
Novartis Investigative Site
Beijing, 100730
ChinaActive - Recruiting
Novartis Investigative Site
Shanghai, 200025
ChinaSite Not Available
Novartis Investigative Site
Shenyang, 110004
ChinaActive - Recruiting
Novartis Investigative Site
Tianjin, 300020
ChinaActive - Recruiting
Novartis Investigative Site
Ostrava, Poruba 708 52
CzechiaActive - Recruiting
Novartis Investigative Site
Brno Bohunice, 625 00
CzechiaActive - Recruiting
Novartis Investigative Site
Brno-Bohunice, 639 00
CzechiaSite Not Available
Novartis Investigative Site
Copenhagen, DK-2100
DenmarkActive - Recruiting
Novartis Investigative Site
Kobenhavn O, DK-2100
DenmarkSite Not Available
Novartis Investigative Site
Bordeaux, 33076
FranceActive - Recruiting
Novartis Investigative Site
Lyon, 69373
FranceActive - Recruiting
Novartis Investigative Site
Marseille, 13273
FranceActive - Recruiting
Novartis Investigative Site
Nantes Cedex 1, 44093
FranceActive - Recruiting
Novartis Investigative Site
Paris 10, 75475
FranceActive - Recruiting
Novartis Investigative Site
Paris Cedex 10, 75475
FranceSite Not Available
Novartis Investigative Site
Vandoeuvre Les Nancy, 54511
FranceActive - Recruiting
Novartis Investigative Site
Frankfurt am Main, Hessen 60590
GermanyActive - Recruiting
Novartis Investigative Site
Berlin, 13353
GermanyActive - Recruiting
Novartis Investigative Site
Frankfurt, 60590
GermanySite Not Available
Novartis Investigative Site
Jena, 07740
GermanyActive - Recruiting
Novartis Investigative Site
Kiel, 24116
GermanyActive - Recruiting
Novartis Investigative Site
Milano, MI 20162
ItalyActive - Recruiting
Novartis Investigative Site
Roma, RM 00161
ItalyActive - Recruiting
Novartis Investigative Site
Napoli, 80132
ItalyCompleted
Novartis Investigative Site
Kobe shi, 650-0017
JapanSite Not Available
Novartis Investigative Site
Kobe-shi, 650-0017
JapanSite Not Available
Novartis Investigative Site
Uijeongbu si, Gyeonggi Do 11759
Korea, Republic ofSite Not Available
Novartis Investigative Site
Busan, 49201
Korea, Republic ofCompleted
Novartis Investigative Site
Jeollanam, 519763
Korea, Republic ofCompleted
Novartis Investigative Site
Jeollanam-do, 519763
Korea, Republic ofSite Not Available
Novartis Investigative Site
Seoul, 03080
Korea, Republic ofActive - Recruiting
Novartis Investigative Site
Beirut, 1107 2020
LebanonSite Not Available
Novartis Investigative Site
Johor Bahru, 80100
MalaysiaActive - Recruiting
Novartis Investigative Site
Pulau Pinang, 10990
MalaysiaActive - Recruiting
Novartis Investigative Site
Selangor, 68000
MalaysiaActive - Recruiting
Novartis Investigative Site
Monterrey, Nuevo Leon 64460
MexicoActive - Recruiting
Novartis Investigative Site
Katowice, 40-519
PolandActive - Recruiting
Novartis Investigative Site
Krakow, 30-688
PolandSite Not Available
Novartis Investigative Site
Warszawa, 00-791
PolandActive - Recruiting
Novartis Investigative Site
Wroclaw, 50 367
PolandCompleted
Novartis Investigative Site
Lisboa, 1099 023
PortugalActive - Recruiting
Novartis Investigative Site
Porto, 4200-072
PortugalSite Not Available
Novartis Investigative Site
Timisoara, 300079
RomaniaActive - Recruiting
Novartis Investigative Site
Moscow, 125284
Russian FederationSite Not Available
Novartis Investigative Site
Saint Petersburg, 197341
Russian FederationActive - Recruiting
Novartis Investigative Site
St Petersburg, 191024
Russian FederationSite Not Available
Novartis Investigative Site
Riyadh, 11211
Saudi ArabiaSite Not Available
Novartis Investigative Site
Singapore, 169608
SingaporeSite Not Available
Novartis Investigative Site
Sevilla, Andalucia 41009
SpainActive - Recruiting
Novartis Investigative Site
Badalona, Catalunya 08916
SpainActive - Recruiting
Novartis Investigative Site
Barcelona, Catalunya 08036
SpainActive - Recruiting
Novartis Investigative Site
Hospitalet de LLobregat, Catalunya 08907
SpainActive - Recruiting
Novartis Investigative Site
Santiago De Compostela, Galicia 15706
SpainActive - Recruiting
Novartis Investigative Site
Bilbao, Pais Vasco 48013
SpainActive - Recruiting
Novartis Investigative Site
Madrid, 28041
SpainActive - Recruiting
Novartis Investigative Site
Santa Cruz de Tenerife, 38009
SpainActive - Recruiting
Novartis Investigative Site
Valencia, 46026
SpainActive - Recruiting
Novartis Investigative Site
Taoyuan, 33305
TaiwanSite Not Available
Novartis Investigative Site
Samsun, 55139
TurkeyActive - Recruiting
Novartis Investigative Site
London, W12 0HS
United KingdomActive - Recruiting
Novartis Investigative Site
Oxford, OX3 7LE
United KingdomActive - Recruiting
Michigan Med University of Michigan
Ann Arbor, Michigan 48109 5271
United StatesActive - Recruiting
Michigan Med University of Michigan .
Ann Arbor, Michigan 48109 5271
United StatesActive - Recruiting
Michigan Medicine University of Michigan
Ann Arbor, Michigan 48109 5271
United StatesActive - Recruiting
Memorial Sloan Kettering
New York, New York 10017
United StatesActive - Recruiting
Oregon Health Sciences University
Portland, Oregon 97239
United StatesSite Not Available
Oregon Health Sciences University .
Portland, Oregon 97239
United StatesSite Not Available
Oregon Health and Science Univ
Portland, Oregon 97239
United StatesActive - Recruiting
Oregon Health and Science University
Portland, Oregon 97239
United StatesActive - Recruiting
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas 77030
United StatesActive - Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.