CABL001A2001B = Asciminib Roll-over Study [Asia-Pacific, Europe, Middle East, Central America, North America, South America]
Type of study
Therapy optimization study
Phase
Current status
Recruiting
Study title
Asciminib Roll-over Study
Scientific title
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
Other trial ID
CABL001A2001B; EudraCT no. 2021-000602-17; ClinicalTrials.gov NCT04877522
What is the purpose of the study
This is a study to assess long term safety in patients who have completed an asciminib study sponsored by Novartis (a so-called parent study) and who, in the opinion of the investigator, would benefit from continued treatment or from switching to asciminib, but are unable to get this treatment outside of the clinical study.
What will happen during the study
Eligible patients who have completed a study on asciminib will either continue treatment as in the parent study or switch to asciminib (if they were on bosutinib in the parent study).
Key inclusion criteria
This study includes patients of all sexes who:
- are aged 18 years or older
- have Philadelphia chromosome positive chronic myeloid leukemia (PH+ CML) or Philadelphia chromosome positive acute lymphoid leukemia (PH+ ALL)
- are currently receiving asciminib (alone or in combination with imatinib, nilotinib or dasatinib), imatinib, nilotinib or bosutinib alone within a study sponsored by Novartis
- in the opinion of the Investigator, would benefit from continued treatment.
Further criteria may apply. Please discuss these with your doctor or study staff.
Key exclusion criteria
This study does not include patients who:
- have been discontinued from treatment in the parent study
- have ongoing unwanted effects that are possibly related to study treatment in the parent study
- are receiving treatment that is currently approved and reimbursed in their country
- are pregnant or breast-feeding.
Further criteria may apply. Please discuss these with your doctor or study staff.
Estimated primary completion date
Where can I find additional information
You can find a study description in the US registry ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.
You can also find a study description in the EU Clinical Trials Registry. This is a database hosted by the European Medicines Agency (EMA).
Study sponsor
Novartis Pharmaceuticals
Scientific lead / contact
Novartis Pharmaceuticals
Principal investigator
Novartis Pharmaceuticals
Study centers / principal investigators
Argentina
Novartis Investigative Site
Caba, Buenos Aires, C1221ADC
Brazil
Novartis Investigative Site
Rio de Janeiro, 20211-030
Novartis Investigative Site
Sao Paulo, 05403-000
Novartis Investigative Site
Sao Paulo, 08270-000
Bulgaria
Novartis Investigative Site
Varna, 9010
Canada
Novartis Investigative Site
Montreal, Quebec, H1T 2M4
Czechia
Novartis Investigative Site
Brno Bohunice, 639 00
Novartis Investigative Site
Ostrava, Poruba, 708 52
Denmark
Novartis Investigative Site
Copenhagen, 2100
France
Novartis Investigative Site
Bordeaux, 33076
Novartis Investigative Site
Marseille, 13273
Novartis Investigative Site
Nantes Cedex 1, 44093
Novartis Investigative Site
Paris Cedex 10, 75475
Novartis Investigative Site
Vandoeuvre les Nancy cedex, 54511
Germany
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Jena, 07743
Italy
Novartis Investigative Site
Milano, 20162
Novartis Investigative Site
Roma, 00161
Novartis Investigative Site
Napoli, 80132
Japan
Novartis Investigative Site
Kobe-shi, Hyogo, 650-0017
Korea, Republic of
Novartis Investigative Site
Uijeongbu si, Gyeonggi Do, 11759
Novartis Investigative Site
Busan, 49201
Novartis Investigative Site
Jeollanam, 519763
Lebanon
Novartis Investigative Site
Beirut, 1107 2020
Mexico
Novartis Investigative Site
Monterrey, Nuevo Leon, 84460
Poland
Novartis Investigative Site
Krakow, 31-501
Novartis Investigative Site
Warszawa, 02 776
Novartis Investigative Site
Wroclaw, 50 367
Portugal
Novartis Investigative Site
Lisboa, 1099 023
Novartis Investigative Site
Porto, 4200 072
Romania
Novartis Investigative Site
Timisoara, 300079
Russian Federation
Novartis Investigative Site
Moscow, 125167
Novartis Investigative Site
Moscow, 125284
Novartis Investigative Site
Saint Petersburg, 197341
Novartis Investigative Site
Saint Petersburg, 191024
Singapore
Novartis Investigative Site
Singapore, 169608
Spain
Novartis Investigative Site
Barcelona, 41009
Novartis Investigative Site
Bilbao, 48013
Novartis Investigative Site
Hospitalet de LLobregat, 08907
Novartis Investigative Site
Madrid, 28006
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Sevilla, 41009
Novartis Investigative Site
Valencia, 46026
Taiwan
Novartis Investigative Site
Taoyuan, 33305
Turkey
Novartis Investigative Site
Samsun, 55139
United Kingdom
Novartis Investigative Site
Oxford, OX3 7LJ
United States
Michigan
Michigan Medicine University of Michigan
Ann Arbor, Michigan, 48109 5271
Principal Investigator: Moshe Talpaz
New York
Memorial Sloan Kettering
New York, New York, 10017
Principal Investigator: Michael Mauro
Oregon
Oregon Health and Science University
Portland, Oregon, 97239
Principal Investigator: Michael Charles Heinrich
Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Principal Investigator: Koji Sasaki