An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment
Status: Recruiting
Location: See all (81) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 100
Healthy Volunteers: f
View:
• 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.
Locations
United States
Michigan
Michigan Med University of Michigan
RECRUITING
Ann Arbor
New York
Memorial Sloan Kettering
RECRUITING
New York
Oregon
Oregon Health Sciences University
ACTIVE_NOT_RECRUITING
Portland
Texas
Uni Of TX MD Anderson Cancer Cntr
RECRUITING
Houston
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
Capital Federal
Austria
Novartis Investigative Site
RECRUITING
Graz
Novartis Investigative Site
RECRUITING
Vienna
Brazil
Novartis Investigative Site
RECRUITING
Rio De Janeiro
Novartis Investigative Site
RECRUITING
São Paulo
Novartis Investigative Site
RECRUITING
São Paulo
Bulgaria
Novartis Investigative Site
RECRUITING
Varna
Canada
Novartis Investigative Site
RECRUITING
Montreal
China
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Changchun
Novartis Investigative Site
RECRUITING
Chengdu
Novartis Investigative Site
RECRUITING
Chongqing
Novartis Investigative Site
RECRUITING
Guangzhou
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Shanghai
Novartis Investigative Site
RECRUITING
Shenyang
Novartis Investigative Site
RECRUITING
Tianjin
Novartis Investigative Site
RECRUITING
Wuhan
Novartis Investigative Site
RECRUITING
Xian
Novartis Investigative Site
RECRUITING
Zhengzhou
Denmark
Novartis Investigative Site
COMPLETED
Copenhagen
France
Novartis Investigative Site
RECRUITING
Bordeaux
Novartis Investigative Site
RECRUITING
Lyon
Novartis Investigative Site
RECRUITING
Marseille
Novartis Investigative Site
RECRUITING
Nantes
Novartis Investigative Site
RECRUITING
Paris
Novartis Investigative Site
RECRUITING
Vandœuvre-lès-nancy
Germany
Novartis Investigative Site
RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
Frankfurt Am Main
Novartis Investigative Site
RECRUITING
Jena
Novartis Investigative Site
RECRUITING
Kiel
Italy
Novartis Investigative Site
RECRUITING
Milan
Novartis Investigative Site
COMPLETED
Napoli
Novartis Investigative Site
RECRUITING
Roma
Japan
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Kobe
Lebanon
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Beirut
Malaysia
Novartis Investigative Site
RECRUITING
George Town
Novartis Investigative Site
RECRUITING
Johor Bahru
Novartis Investigative Site
RECRUITING
Kuala Selangor
Mexico
Novartis Investigative Site
RECRUITING
Monterrey
Oman
Novartis Investigative Site
RECRUITING
Khoudh
Poland
Novartis Investigative Site
RECRUITING
Katowice
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Krakow
Novartis Investigative Site
RECRUITING
Warsaw
Novartis Investigative Site
COMPLETED
Wroclaw
Portugal
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Lisbon
Novartis Investigative Site
RECRUITING
Porto
Republic of Korea
Novartis Investigative Site
COMPLETED
Busan
Novartis Investigative Site
COMPLETED
Jeollanam
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Uijeongbu-si
Romania
Novartis Investigative Site
RECRUITING
Timișoara
Russian Federation
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Moscow
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Moscow
Novartis Investigative Site
RECRUITING
Saint Petersburg
Novartis Investigative Site
RECRUITING
Saint Petersburg
Saudi Arabia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Riyadh
Singapore
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Singapore
Spain
Novartis Investigative Site
RECRUITING
Badalona
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Bilbao
Novartis Investigative Site
RECRUITING
L'hospitalet De Llobregat
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Santa Cruz De Tenerife
Novartis Investigative Site
RECRUITING
Santiago De Compostela
Novartis Investigative Site
RECRUITING
Seville
Novartis Investigative Site
RECRUITING
Valencia
Taiwan
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Taoyuan District
Turkey
Novartis Investigative Site
RECRUITING
Samsun
United Kingdom
Novartis Investigative Site
RECRUITING
London
Novartis Investigative Site
RECRUITING
Oxford
Viet Nam
Novartis Investigative Site
RECRUITING
Hanoi
Novartis Investigative Site
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2022-08-30
Estimated Completion Date: 2030-08-30
Participants
Target number of participants: 347
Treatments
Experimental: Asciminib single agent group
Participants with CML or ALL, from Novartis sponsored asciminib studies, including but not limited to CABL001A2301, CABL001A2302, CABL001X2101, CABL001A2202, CABL001AUS04 and CABL001AUS08 studies, that were receiving asciminib
Other: Bosutinib single agent group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301, that were receiving bosutinib
Experimental: Bosutinib-Asciminib switch group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301 that were receiving bosutinib treatment and switched to asciminib when entering this study or during the course of this study
Experimental: Asciminib in combination with imatinib group
Participants with CML from Novartis sponsored asciminib studies CABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib
Experimental: Asciminib in combination with nilotinib group
Participants with CML or ALL from Novartis sponsored asciminib studies CABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib
Other: Imatinib single agent group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 that were receiving imatinib
Other: Nilotinib single agent group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 and CABL001J12302 that were receiving nilotinib
Experimental: Asciminib in combination with dasatinib group
Participants with CML from Novartis sponsored study CABL001X2101 that were receiving asciminib with dasatinib
Other: Dasatinib single agent group
Participant with CML-CP , from Novartis sponsored asciminib study CABL001A2202, CABL001J12301, that were receiving Dasatinib.
Experimental: Dasatinib-Asciminib switch group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2202 that were receiving best available therapy (dasatinib) and switched to asciminib when entering this study or during the course of this study
Experimental: Asciminib single agent formulation for Pediatric
Participants with CML, from Novartis sponsored asciminib studies, including but not limited to CABL001I12201 study, that were receiving asciminib
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals