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.

Condition(s) studied

Investigational drug(s) / intervention(s)

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)

Study 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.

Eligibility

Primary outcome measure(s)

• Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — 5 years
  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.
• Severity of AEs and SAEs — 5 years
  Severity of AEs and SAEs will be measured according to the CTCAE v5.0

Trial sites (24)