Chronic Myelogenous Leukemia Clinical Trial
Official 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
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
Status | Recruiting |
Enrollment | 347 |
Est. completion date | August 30, 2030 |
Est. primary completion date | August 29, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria: 1. 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. 2. 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: 1. Participant has been discontinued from parent study treatment. 2. Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study. 3. Participant's ongoing treatment is currently approved and reimbursed at country level. 4. Pregnant or nursing (lactating) women. 5. Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment. 6. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information. 7. Applicable only for participants on bosutinib treatment that switch to asciminib treatment at enrollment: - Asymptomatic pancreatitis - abnormal ECG - 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. |
Country | Name | City | State |
---|---|---|---|
Argentina | Novartis Investigative Site | Caba | Buenos Aires |
Austria | Novartis Investigative Site | Wien | |
Brazil | Novartis Investigative Site | Rio de Janeiro | RJ |
Brazil | Novartis Investigative Site | Sao Paulo | SP |
Brazil | Novartis Investigative Site | Sao Paulo | SP |
Bulgaria | Novartis Investigative Site | Varna | |
Canada | Novartis Investigative Site | Montreal | Quebec |
Czechia | Novartis Investigative Site | Brno-Bohunice | |
Czechia | Novartis Investigative Site | Ostrava | Poruba |
Denmark | Novartis Investigative Site | Copenhagen | |
France | Novartis Investigative Site | Bordeaux | |
France | Novartis Investigative Site | Marseille | |
France | Novartis Investigative Site | Paris 10 | |
France | Novartis Investigative Site | Vandoeuvre les Nancy | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Frankfurt | |
Germany | Novartis Investigative Site | Jena | |
Italy | Novartis Investigative Site | Milano | MI |
Italy | Novartis Investigative Site | Napoli | |
Italy | Novartis Investigative Site | Roma | RM |
Japan | Novartis Investigative Site | Kobe-shi | Hyogo |
Korea, Republic of | Novartis Investigative Site | Busan | |
Korea, Republic of | Novartis Investigative Site | Jeollanam | |
Korea, Republic of | Novartis Investigative Site | Uijeongbu si | Gyeonggi Do |
Lebanon | Novartis Investigative Site | Beirut | |
Mexico | Novartis Investigative Site | Monterrey | Nuevo Leon |
Poland | Novartis Investigative Site | Krakow | |
Poland | Novartis Investigative Site | Warszawa | |
Poland | Novartis Investigative Site | Wroclaw | |
Portugal | Novartis Investigative Site | Lisboa | |
Portugal | Novartis Investigative Site | Porto | |
Romania | Novartis Investigative Site | Timisoara | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Saint Petersburg | |
Russian Federation | Novartis Investigative Site | St Petersburg | |
Saudi Arabia | Novartis Investigative Site | Riyadh | |
Singapore | Novartis Investigative Site | Singapore | |
Spain | Novartis Investigative Site | Barcelona | Catalunya |
Spain | Novartis Investigative Site | Bilbao | Pais Vasco |
Spain | Novartis Investigative Site | Hospitalet de LLobregat | Catalunya |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Sevilla | Andalucia |
Spain | Novartis Investigative Site | Valencia | |
Taiwan | Novartis Investigative Site | Taoyuan | |
Turkey | Novartis Investigative Site | Samsun | |
United Kingdom | Novartis Investigative Site | Oxford | |
United States | Michigan Med University of Michigan . | Ann Arbor | Michigan |
United States | Uni of TX MD Anderson Cancer Cntr | Houston | Texas |
United States | Memorial Sloan Kettering | New York | New York |
United States | Oregon Health Sciences University . | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Argentina, Austria, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Germany, Italy, Japan, Korea, Republic of, Lebanon, Mexico, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participabts with adverse events (AEs) and serious adverse events (SAEs) | All AEs and SAEs will be tabulated and listed for participants in the Safety Set by treatment group. From day of first administration of study treatment to 30 days after the last study treatment. | 5 years | |
Secondary | Percentage of participants with clinical benefit as assessed by Investigator | Investigators' assessment of clinical benefit will collected through the Investigator confirming that the patient is still benefiting from treatment. This will be evaluated and tabulated for participants in the Safety Set by treatment group at each visit. | 5 years |
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