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 (38) 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: 18
Healthy Volunteers: No
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
Other Locations
Argentina
Novartis Investigative Site
Recruiting
Caba
Brazil
Novartis Investigative Site
Recruiting
Rio De Janeiro
Novartis Investigative Site
Recruiting
Sao Paulo
Novartis Investigative Site
Recruiting
Sao Paulo
Bulgaria
Novartis Investigative Site
Recruiting
Varna
Canada
Novartis Investigative Site
Recruiting
Montreal
Denmark
Novartis Investigative Site
Recruiting
Copenhagen
France
Novartis Investigative Site
Recruiting
Bordeaux
Novartis Investigative Site
Recruiting
Paris Cedex 10
Germany
Novartis Investigative Site
Recruiting
Frankfurt
Novartis Investigative Site
Recruiting
Jena
Italy
Novartis Investigative Site
Recruiting
Milano
Novartis Investigative Site
Recruiting
Napoli
Novartis Investigative Site
Recruiting
Roma
Lebanon
Novartis Investigative Site
Recruiting
Beirut
Mexico
Novartis Investigative Site
Recruiting
Monterrey
Poland
Novartis Investigative Site
Recruiting
Krakow
Novartis Investigative Site
Recruiting
Warszawa
Novartis Investigative Site
Recruiting
Wroclaw
Portugal
Novartis Investigative Site
Recruiting
Lisboa
Novartis Investigative Site
Recruiting
Porto
Republic of Korea
Novartis Investigative Site
Recruiting
Busan
Novartis Investigative Site
Recruiting
Jeollanam-do
Novartis Investigative Site
Recruiting
Uijeongbu Si
Romania
Novartis Investigative Site
Recruiting
Timisoara
Russian Federation
Novartis Investigative Site
Recruiting
Moscow
Novartis Investigative Site
Recruiting
Moscow
Novartis Investigative Site
Recruiting
Saint Petersburg
Novartis Investigative Site
Recruiting
St Petersburg
Singapore
Novartis Investigative Site
Recruiting
Singapore
Spain
Novartis Investigative Site
Recruiting
Barcelona
Novartis Investigative Site
Recruiting
Bilbao
Novartis Investigative Site
Recruiting
Hospitalet De Llobregat
Novartis Investigative Site
Recruiting
Madrid
Novartis Investigative Site
Recruiting
Madrid
Novartis Investigative Site
Recruiting
Sevilla
Novartis Investigative Site
Recruiting
Valencia
Turkey
Novartis Investigative Site
Recruiting
Samsun
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: August 30, 2022
Estimated Completion Date: August 30, 2027
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 ABL001A2301, ABL001X2101 and ABL001A2202 studies, that were receiving asciminib
Other: Bosutinib single agent group
Participants with CML-CP, from Novartis sponsored asciminib study ABL001A2301, that were receiving bosutinib
Experimental: Bosutinib-asciminib switch group
Participants with CML-CP, from Novartis sponsored asciminib study ABL001A2301 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 ABL001E2201 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 ABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib
Other: Imatinib single agent group
Participants with CML-CP, from Novartis sponsored asciminib study ABL001E2201 that were receiving imatinib
Other: Nilotinib single agent group
Participants with CML-CP, from Novartis sponsored asciminib study ABL001E2201 that were receiving nilotinib
Experimental: Asciminib in combination with dasatinib group
Participants with CML from Novartis sponsored study ABL001X2101 that were receiving asciminib with dasatinib
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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