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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.
Sponsor: Novartis Pharmaceuticals
Summary
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.
Official title: 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.
Key Details
Gender
All
Age Range
12 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2023-02-13
Completion Date
2028-02-14
Last Updated
2026-01-07
Healthy Volunteers
No
Interventions
decitabine
Solution for intravenous infusion
spartalizumab
Solution for intravenous infusion
sabatolimab
Solution for intravenous infusion
azacitidine
Solution for subcutaneous injection or intravenous infusion
venetoclax
Tablet for oral administration
INQOVI (oral decitabine)
Tablet for oral administration. HMA = azactidine or decitabine INQOVI = decitabine (oral)
Locations (24)
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
Novartis Investigative Site
Alexandroupoli, Greece
Novartis Investigative Site
Pátrai, Greece
Novartis Investigative Site
Brescia, BS, Italy
Novartis Investigative Site
Florence, FI, Italy
Novartis Investigative Site
Genova, GE, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Fukushima, Japan
Novartis Investigative Site
Kuala Lumpur, Malaysia
Novartis Investigative Site
Badalona, Barcelona, Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Zurich, Switzerland
Novartis Investigative Site
Izmir, Turkey (Türkiye)