Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
Conditions
Keywords
roll-over study, MBG453, sabatolimab, azacitidine, decitabine, venetoclax, spartalizumab, HMA, INQOVI (oral decitabine)
Brief 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.
Detailed description
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.
Interventions
DRUGdecitabine
Solution for intravenous infusion
DRUGspartalizumab
Solution for intravenous infusion
DRUGsabatolimab
Solution for intravenous infusion
DRUGazacitidine
Solution for subcutaneous injection or intravenous infusion
DRUGvenetoclax
Tablet for oral administration
Tablet for oral administration. HMA = azactidine or decitabine INQOVI = decitabine (oral)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
12 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Participant is currently enrolled in a Novartis-sponsored study with sabatolimab, is being treated with sabatolimab, and has fulfilled all requirements in the parent study. 2. Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines of the parent protocol and investigator's judgment. 3. Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements. 4. Willingness and ability to comply with scheduled visits, treatment plan and any other study procedures. 5. Written informed consent obtained prior to enrolling in the roll-over study.
Exclusion criteria
1. Participants in cohorts or treatment groups not receiving sabatolimab in the parent protocol. 2. Participant has been permanently discontinued from sabatolimab treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason. 3. Participant currently has unresolved toxicities for which sabatolimab dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow sabatolimab dosing to resume). 4. Pregnant or nursing (lactating) women. Where pregnancy is defined as the state of a female after conception confirmed by a positive serum hCG laboratory test and until the termination of gestation. 5. Participant not willing to comply with the contraception requirements outlined in the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of exposure to sabatolimab | 5 years | The length of time patients will be exposed to sabatolimab and will be reported by treatment groups. |
Countries
Australia, Brazil, Canada, China, Czechia, France, Germany, Greece, Italy, Japan, Malaysia, Spain, Switzerland, Turkey (Türkiye), United States
Outcome results
None listed