Phase
Condition
Leukemia
Red Blood Cell Disorders
White Cell Disorders
Treatment
Asciminib
Bosutinib
Asciminib single agent pediatric formulation
Clinical Study ID
Ages 7-100 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
ArgentinaActive - Recruiting
Novartis Investigative Site
CABA, Buenos Aires 3435907 C1221ADC
ArgentinaActive - Recruiting
Novartis Investigative Site
Capital Federal, C1114AAN
ArgentinaActive - Recruiting
Novartis Investigative Site
Graz, 8036
AustriaSite Not Available
Novartis Investigative Site
Graz 2778067, 8036
AustriaActive - Recruiting
Novartis Investigative Site
Vienna 2761369, 1140
AustriaActive - Recruiting
Novartis Investigative Site
Wien, 1140
AustriaSite Not Available
Novartis Investigative Site
Rio de Janeiro, RJ 20211-030
BrazilSite Not Available
Novartis Investigative Site
Rio de Janeiro 3451190, Rio de Janeiro 3451189 20211-030
BrazilActive - Recruiting
Novartis Investigative Site
Sao Paulo, SP 08270-070
BrazilSite Not Available
Novartis Investigative Site
São Paulo 3448439, São Paulo 3448433 08270-070
BrazilActive - Recruiting
Novartis Investigative Site
Varna, 9000
BulgariaSite Not Available
Novartis Investigative Site
Varna 726050, 9000
BulgariaActive - Recruiting
Novartis Investigative Site
Montreal, Quebec H1T 2M4
CanadaSite Not Available
Novartis Investigative Site
Montreal 6077243, Quebec 6115047 H1T 2M4
CanadaActive - Recruiting
Novartis Investigative Site
Chongqing, Chongqing 400010
ChinaSite Not Available
Novartis Investigative Site
Chongqing 1814906, Chongqing Municipality 1814905 400010
ChinaActive - Recruiting
Novartis Investigative Site
Guangzhou, Guangdong 510515
ChinaSite Not Available
Novartis Investigative Site
Guangzhou 1809858, Guangdong 1809935 510515
ChinaActive - Recruiting
Novartis Investigative Site
Zhengzhou, Henan 450008
ChinaSite Not Available
Novartis Investigative Site
Zhengzhou 1784658, Henan 1808520 450008
ChinaActive - Recruiting
Novartis Investigative Site
Wuhan, Hubei 430022
ChinaSite Not Available
Novartis Investigative Site
Wuhan 1791247, Hubei 1806949 430022
ChinaActive - Recruiting
Novartis Investigative Site
Chang Chun, Jilin 130021
ChinaSite Not Available
Novartis Investigative Site
Changchun 2038180, Jilin 2036500 130021
ChinaActive - Recruiting
Novartis Investigative Site
Xian, Shanxi 1795912 710004
ChinaActive - Recruiting
Novartis Investigative Site
Chengdu, Sichuan 610041
ChinaSite Not Available
Novartis Investigative Site
Chengdu 1815286, Sichuan 1794299 610041
ChinaCompleted
Novartis Investigative Site
Beijing, 100044
ChinaSite Not Available
Novartis Investigative Site
Beijing 1816670, 100730
ChinaActive - Recruiting
Novartis Investigative Site
Shanghai, 200025
ChinaSite Not Available
Novartis Investigative Site
Shanghai 1796236, 200025
ChinaSite Not Available
Novartis Investigative Site
Shenyang, 110004
ChinaSite Not Available
Novartis Investigative Site
Shenyang 2034937, 110004
ChinaActive - Recruiting
Novartis Investigative Site
Tianjin, 300020
ChinaSite Not Available
Novartis Investigative Site
Tianjin 1792947, 300020
ChinaActive - Recruiting
Novartis Investigative Site
Ostrava, Poruba 708 52
CzechiaSite Not Available
Novartis Investigative Site
Ostrava 3068799, Poruba 708 52
CzechiaActive - Recruiting
Novartis Investigative Site
Brno, 625 00
CzechiaSite Not Available
Novartis Investigative Site
Brno 3078610, 625 00
CzechiaActive - Recruiting
Novartis Investigative Site
Brno Bohunice, 625 00
CzechiaSite Not Available
Novartis Investigative Site
Brno-Bohunice, 639 00
CzechiaSite Not Available
Novartis Investigative Site
Copenhagen, DK-2100
DenmarkSite Not Available
Novartis Investigative Site
Copenhagen 2618425, DK-2100
DenmarkCompleted
Novartis Investigative Site
Kobenhavn O, DK-2100
DenmarkSite Not Available
Novartis Investigative Site
Bordeaux, 33076
FranceSite Not Available
Novartis Investigative Site
Bordeaux 3031582, 33076
FranceActive - Recruiting
Novartis Investigative Site
Lyon, 69373
FranceSite Not Available
Novartis Investigative Site
Lyon 2996944, 69373
FranceActive - Recruiting
Novartis Investigative Site
Marseille, 13273
FranceSite Not Available
Novartis Investigative Site
Marseille 2995469, 13273
FranceActive - Recruiting
Novartis Investigative Site
Nantes, 44093
FranceSite Not Available
Novartis Investigative Site
Nantes 2990969, 44093
FranceActive - Recruiting
Novartis Investigative Site
Nantes Cedex 1, 44093
FranceSite Not Available
Novartis Investigative Site
Paris 2988507, 75475
FranceActive - Recruiting
Novartis Investigative Site
Paris 10, 75475
FranceSite Not Available
Novartis Investigative Site
Paris Cedex 10, 75475
FranceSite Not Available
Novartis Investigative Site
Vandoeuvre les Nancy, 54511
FranceSite Not Available
Novartis Investigative Site
Vandœuvre-lès-Nancy 2970797, 54511
FranceActive - Recruiting
Novartis Investigative Site
Frankfurt am Main 2925533, Hesse 2905330 60590
GermanyActive - Recruiting
Novartis Investigative Site
Frankfurt, Hessen 60590
GermanySite Not Available
Novartis Investigative Site
Frankfurt am Main, Hessen 60590
GermanySite Not Available
Novartis Investigative Site
Jena, Thueringen 07740
GermanySite Not Available
Novartis Investigative Site
Jena 2895044, Thuringia 2822542 07740
GermanyActive - Recruiting
Novartis Investigative Site
Berlin, 13353
GermanySite Not Available
Novartis Investigative Site
Berlin 2950159, 13353
GermanyActive - Recruiting
Novartis Investigative Site
Kiel, 24116
GermanySite Not Available
Novartis Investigative Site
Kiel 2891122, 24116
GermanyActive - Recruiting
Novartis Investigative Site
Milan 6951411, MI 20162
ItalyActive - Recruiting
Novartis Investigative Site
Milano, MI 20162
ItalySite Not Available
Novartis Investigative Site
Roma, RM 00161
ItalySite Not Available
Novartis Investigative Site
Roma 8957247, RM 00161
ItalyActive - Recruiting
Novartis Investigative Site
Napoli, 80132
ItalySite Not Available
Novartis Investigative Site
Napoli 9031661, 80131
ItalyCompleted
Novartis Investigative Site
Kobe 1859171, 650-0017
JapanSite Not Available
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 ofSite Not Available
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 ofSite Not Available
Novartis Investigative Site
Beirut, 1107 2020
LebanonSite Not Available
Novartis Investigative Site
Beirut 276781, 113-0236
LebanonCompleted
Novartis Investigative Site
Georgetown, Pulau Pinang 10450
MalaysiaSite Not Available
Novartis Investigative Site
George Town 1735106, Pulau Pinang 1733047 10450
MalaysiaActive - Recruiting
Novartis Investigative Site
Johor Bahru, 80100
MalaysiaSite Not Available
Novartis Investigative Site
Johor Bahru 1732752, 80100
MalaysiaActive - Recruiting
Novartis Investigative Site
Kuala Selangor 1732891, 68000
MalaysiaActive - Recruiting
Novartis Investigative Site
Pulau Pinang, 10990
MalaysiaSite Not Available
Novartis Investigative Site
Selangor, 68000
MalaysiaSite Not Available
Novartis Investigative Site
Monterrey, Nuevo Leon 64460
MexicoSite Not Available
Novartis Investigative Site
Monterrey 3995465, Nuevo León 3522542 64460
MexicoActive - Recruiting
Novartis Investigative Site
Khoudh, 123
OmanActive - Recruiting
Novartis Investigative Site
Muscat, 123
OmanSite Not Available
Novartis Investigative Site
Muscat 287286, 123
OmanSite Not Available
Novartis Investigative Site
Katowice, 40-519
PolandSite Not Available
Novartis Investigative Site
Katowice 3096472, 40-519
PolandActive - Recruiting
Novartis Investigative Site
Krakow, 30-688
PolandSite Not Available
Novartis Investigative Site
Krakow 3094802, 30-688
PolandCompleted
Novartis Investigative Site
Warsaw 756135, 00-791
PolandActive - Recruiting
Novartis Investigative Site
Warszawa, 00-791
PolandSite Not Available
Novartis Investigative Site
Wroclaw, 50 367
PolandSite Not Available
Novartis Investigative Site
Wroclaw 3081368, 50 367
PolandCompleted
Novartis Investigative Site
Lisboa, 1099-023
PortugalSite Not Available
Novartis Investigative Site
Lisbon 2267057, 1099-023
PortugalSite Not Available
Novartis Investigative Site
Porto, 4200-072
PortugalSite Not Available
Novartis Investigative Site
Porto 2735943, 4200-072
PortugalActive - Recruiting
Novartis Investigative Site
Timisoara, 300079
RomaniaSite Not Available
Novartis Investigative Site
Timișoara 665087, 300079
RomaniaActive - Recruiting
Novartis Investigative Site
Moscow 524901, 125167
RussiaSite Not Available
Novartis Investigative Site
Saint Petersburg 498817, 191024
RussiaActive - Recruiting
Novartis Investigative Site
Moscow, 125167
Russian FederationSite Not Available
Novartis Investigative Site
Saint Petersburg, 191024
Russian FederationSite Not Available
Novartis Investigative Site
St Petersburg, 191024
Russian FederationSite Not Available
Novartis Investigative Site
Riyadh, 11211
Saudi ArabiaSite Not Available
Novartis Investigative Site
Riyadh 108410, 11211
Saudi ArabiaCompleted
Novartis Investigative Site
Singapore, 169608
SingaporeSite Not Available
Novartis Investigative Site
Singapore 1880252, 169608
SingaporeSite Not Available
Novartis Investigative Site
Uijeongbu-si 1833788, Gyeonggi-do 1841610 11759
South KoreaSite Not Available
Novartis Investigative Site
Seoul 1835848, Korea 03080
South KoreaActive - Recruiting
Novartis Investigative Site
Busan 1838524, 49201
South KoreaCompleted
Novartis Investigative Site
Jeollanam, 519763
South KoreaCompleted
Novartis Investigative Site
Santiago Compostela, A Coruna 15706
SpainActive - Recruiting
Novartis Investigative Site
Sevilla, Andalucia 41009
SpainSite Not Available
Novartis Investigative Site
Badalona 3129028, Barcelona 08916
SpainActive - Recruiting
Novartis Investigative Site
Hospitalet de LLobregat, Barcelona 08907
SpainSite Not Available
Novartis Investigative Site
L'Hospitalet de Llobregat 3120619, Barcelona 08907
SpainActive - Recruiting
Novartis Investigative Site
Bilbao, Bizkaia 48013
SpainSite Not Available
Novartis Investigative Site
Bilbao 3128026, Bizkaia 48013
SpainActive - Recruiting
Novartis Investigative Site
Badalona, Catalunya 08916
SpainSite Not Available
Novartis Investigative Site
Santiago De Compostela, Galicia 15706
SpainSite Not Available
Novartis Investigative Site
Santiago de Compostela 3109642, Galicia 3336902 15706
SpainSite Not Available
Novartis Investigative Site
Santa Cruz 2511550, Santa Cruz De Tenerife 38009
SpainActive - Recruiting
Novartis Investigative Site
Barcelona, 08036
SpainSite Not Available
Novartis Investigative Site
Barcelona 3128760, 08035
SpainActive - Recruiting
Novartis Investigative Site
Madrid, 28041
SpainSite Not Available
Novartis Investigative Site
Madrid 3117735, 28006
SpainActive - Recruiting
Novartis Investigative Site
Santa Cruz de Tenerife, 38009
SpainSite Not Available
Novartis Investigative Site
Santa Cruz de Tenerife 2511174, 38009
SpainSite Not Available
Novartis Investigative Site
Seville 2510911, 41009
SpainActive - Recruiting
Novartis Investigative Site
Valencia, 46026
SpainSite Not Available
Novartis Investigative Site
Valencia 2509954, 46026
SpainActive - Recruiting
Novartis Investigative Site
Taoyuan, 33305
TaiwanSite Not Available
Novartis Investigative Site
Taoyuan District 1667905, 33305
TaiwanSite Not Available
Novartis Investigative Site
Samsun, 55139
TurkeySite Not Available
Novartis Investigative Site
Samsun 740264, Atakum 55200
Turkey (Türkiye)Active - Recruiting
Novartis Investigative Site
London, W12 0HS
United KingdomSite Not Available
Novartis Investigative Site
London 2643743, W12 0HS
United KingdomActive - Recruiting
Novartis Investigative Site
Oxford, OX3 7LE
United KingdomSite Not Available
Novartis Investigative Site
Oxford 2640729, OX3 7LE
United KingdomActive - Recruiting
Michigan Med University of Michigan
Ann Arbor, Michigan 48109 5271
United StatesSite Not Available
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
Michigan Med University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109 5271
United StatesActive - Recruiting
Memorial Sloan Kettering
New York, New York 10017
United StatesSite Not Available
Memorial Sloan Kettering
New York 5128581, New York 5128638 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
Oregon Health Sciences University
Portland 5746545, Oregon 5744337 97239
United StatesSite Not Available
Uni of TX MD Anderson Cancer Cntr
Houston, Texas 77030
United StatesSite Not Available
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
Texas Oncology
Dallas 4684888, Texas 4736286 75251
United StatesActive - Recruiting
Uni Of TX MD Anderson Cancer Cntr
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
Novartis Investigative Site
Hanoi, 100000
VietnamSite Not Available
Novartis Investigative Site
Hanoi 1581130, 100000
VietnamActive - Recruiting
Novartis Investigative Site
Ho Chi Minh, 738000
VietnamSite Not Available
Novartis Investigative Site
Ho Chi Minh City 1566083, 70000
VietnamActive - Recruiting

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