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.
- Conditions
- Leukemia, Myelomonocytic, ChronicMyelodysplastic Syndromes
- Interventions
- Drug: INQOVI (oral decitabine)
- Registration Number
- NCT05201066
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 33
- 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.
- Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines of the parent protocol and investigator's judgment.
- Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
- Willingness and ability to comply with scheduled visits, treatment plan and any other study procedures.
- Written informed consent obtained prior to enrolling in the roll-over study.
- Participants in cohorts or treatment groups not receiving sabatolimab in the parent protocol.
- 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.
- 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).
- 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.
- Participant not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol.
- Local access to commercially available sabatolimab for parent protocol indications.
Other protocol-defined Inclusion/Exclusion may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description sabatolimab + venetoclax + azacitidine sabatolimab Patients will take sabatolimab 200 mg i.v./q2w and venetoclax 400 mg p.o. d1-14/q4wk and azacitidine 75 mg/m2/d d1-7/q4w. sabatolimab + spartalizumab + decitabine sabatolimab Patients will take sabatolimab 400 mg i.v./q2w and decitabine 20 mg/m2/d d1-5 i.v. and spartalizumab 100 mg i.v/q2w. sabatolimab + HMA sabatolimab Patients will take sabatolimab 800 mg and azacitidine 75 mg/m2/d d1-7 or decitabine 20 mg/m2/d d1-5/ all q4w HMA means hypomethylating agents. Hypomethylating agents are azacitidine and decitabine. sabatolimab + HMA INQOVI (oral decitabine) Patients will take sabatolimab 800 mg and azacitidine 75 mg/m2/d d1-7 or decitabine 20 mg/m2/d d1-5/ all q4w HMA means hypomethylating agents. Hypomethylating agents are azacitidine and decitabine. sabatolimab + decitabine decitabine Patients will take Sabatolimab 400 mg i.v/q2w and decitabine 20 mg/m2/d d1-5 i.v. sabatolimab sabatolimab Patients will take sabatolimab 800 mg i.v q4w. sabatolimab + azacitidine azacitidine Patients will take sabatolimab 800 mg i.v and azacitidine 75 mg/m2/d d1-7 s.c. or i.v./q4w or sabatolimab 400 mg i.v/q2w and azacitidine 75 mg/m2/d d1-7 s.c. or i.v./q4w. sabatolimab + decitabine sabatolimab Patients will take Sabatolimab 400 mg i.v/q2w and decitabine 20 mg/m2/d d1-5 i.v. sabatolimab + azacitidine sabatolimab Patients will take sabatolimab 800 mg i.v and azacitidine 75 mg/m2/d d1-7 s.c. or i.v./q4w or sabatolimab 400 mg i.v/q2w and azacitidine 75 mg/m2/d d1-7 s.c. or i.v./q4w. sabatolimab + venetoclax + azacitidine azacitidine Patients will take sabatolimab 200 mg i.v./q2w and venetoclax 400 mg p.o. d1-14/q4wk and azacitidine 75 mg/m2/d d1-7/q4w. sabatolimab + spartalizumab + decitabine decitabine Patients will take sabatolimab 400 mg i.v./q2w and decitabine 20 mg/m2/d d1-5 i.v. and spartalizumab 100 mg i.v/q2w. sabatolimab + venetoclax + azacitidine venetoclax Patients will take sabatolimab 200 mg i.v./q2w and venetoclax 400 mg p.o. d1-14/q4wk and azacitidine 75 mg/m2/d d1-7/q4w. sabatolimab + spartalizumab + decitabine spartalizumab Patients will take sabatolimab 400 mg i.v./q2w and decitabine 20 mg/m2/d d1-5 i.v. and spartalizumab 100 mg i.v/q2w.
- Primary Outcome Measures
Name Time Method Severity of AEs and SAEs 5 years Severity of AEs and SAEs will be measured according to the CTCAE v5.0
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.
- Secondary Outcome Measures
Name Time Method Duration of exposure to sabatolimab 5 years The length of time patients will be exposed to sabatolimab and will be reported by treatment groups.
Trial Locations
- Locations (4)
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Huntsman Cancer Institute Univ of Utah
🇺🇸Salt Lake City, Utah, United States
Novartis Investigative Site
🇹🇷Izmir, Turkey