Myeloproliferative Neoplasms Clinical Trial
Asciminib Roll-over Study
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.
Key Inclusion Criteria:
Participant with PH+ leukemia-cml/" >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:
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.
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There are 52 Locations for this study
Caba Buenos Aires, C1221, Argentina
Wien , 1140, Austria
Rio de Janeiro RJ, 20211, Brazil
Sao Paulo SP, 05403, Brazil
Sao Paulo SP, 08270, Brazil
Varna , 9000, Bulgaria
Montreal Quebec, H1T 2, Canada
Ostrava Poruba, 708 5, Czechia
Brno-Bohunice , 639 0, Czechia
Copenhagen , DK-21, Denmark
Bordeaux , 33076, France
Marseille , 13273, France
Paris 10 , 75475, France
Vandoeuvre les Nancy , 54511, France
Berlin , 13353, Germany
Frankfurt , 60590, Germany
Jena , 07740, Germany
Milano MI, 20162, Italy
Roma RM, 00161, Italy
Napoli , 80132, Italy
Kobe-shi Hyogo, 650-0, Japan
Uijeongbu si Gyeonggi Do, 11759, Korea, Republic of
Busan , 49201, Korea, Republic of
Jeollanam , 51976, Korea, Republic of
Beirut , 1107 , Lebanon
Monterrey Nuevo Leon, 64460, Mexico
Krakow , 30-68, Poland
Warszawa , 02 77, Poland
Wroclaw , 50 36, Poland
Lisboa , 1099 , Portugal
Porto , 4200-, Portugal
Timisoara , 30007, Romania
Moscow , 12516, Russian Federation
Moscow , 12528, Russian Federation
Saint Petersburg , 19734, Russian Federation
St Petersburg , 19102, Russian Federation
Riyadh , 11211, Saudi Arabia
Singapore , 16960, Singapore
Sevilla Andalucia, 41009, Spain
Barcelona Catalunya, 08036, Spain
Hospitalet de LLobregat Catalunya, 08907, Spain
Bilbao Pais Vasco, 48013, Spain
Madrid , 28006, Spain
Madrid , 28034, Spain
Valencia , 46026, Spain
Taoyuan , 33305, Taiwan
Samsun , 55139, Turkey
Oxford , OX3 7, United Kingdom
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