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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Solution for intravenous infusion
Solution for intravenous infusion
Solution for intravenous infusion
Solution for subcutaneous injection or intravenous infusion
Tablet for oral administration
Tablet for oral administration. HMA = azactidine or decitabine INQOVI = decitabine (oral)
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
...and 14 more locations
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. An AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. An SAE is defined as any adverse event \[appearance of (or worsening of any pre-existing)\] undesirable sign(s), symptom(s), or medical conditions(s) which meets any one of the following criteria: fatal, life-threatening, results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, may have caused a congenital anomaly/birth defect, requires intervention to prevent permanent impairment or damage.
Time frame: 5 years
Severity of AEs and SAEs
Severity of AEs and SAEs will be measured according to the CTCAE v5.0
Time frame: 5 years
Duration of exposure to sabatolimab
The length of time patients will be exposed to sabatolimab and will be reported by treatment groups.
Time frame: 5 years
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