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An Open-label, Multicenter, Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.
This study is intended to collect safety data from participants who completed the parent protocols but are still benefiting from study treatment. The study population consists of participants who tolerate study treatment of the parent studies. Collecting safety information from long-term exposure might offer the unique opportunity to detect rare Adverse Events.
This is a multicenter, open label, roll-over study to collect and assess safety of sabatolimab in participants who are treated in current Novartis-sponsored parent studies and who are benefiting from continued study treatment including sabatolimab as judged by the investigator. There is no conventional screening period in this study as participants are expected to transition directly from treatment on the parent protocol to treatment on this roll-over protocol. Participants who are candidates for the roll-over protocol will be evaluated by the investigator in the parent protocol for eligibility for the roll-over protocol. If eligible, the parent protocol end of treatment visit will be performed and the informed consent for the roll-over protocol will be signed. Participants then continue treatment on this protocol with the next planned dose of sabatolimab as monotherapy or with other combination agent(s). The treatment with sabatolimab and combination agent(s), as applicable, is continued according to the schedule in the parent study. Adverse events (AEs) will be collected continuously throughout the study and participants will be questioned about adverse events at each visit.
Age
12 - 99 years
Sex
ALL
Healthy Volunteers
No
Oregon Health Sciences University
Portland, Oregon, United States
Huntsman Cancer Institute Univ of Utah
Salt Lake City, Utah, United States
Novartis Investigative Site
Clayton, Victoria, Australia
Novartis Investigative Site
Florianópolis, Santa Catarina, Brazil
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Tianjin, China
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Toulouse, France
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Start Date
February 13, 2023
Primary Completion Date
February 14, 2028
Completion Date
February 14, 2028
Last Updated
January 7, 2026
33
ACTUAL participants
decitabine
DRUG
spartalizumab
DRUG
sabatolimab
DRUG
azacitidine
DRUG
venetoclax
DRUG
INQOVI (oral decitabine)
DRUG
Lead Sponsor
Novartis Pharmaceuticals
NCT07270978
NCT05292664
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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