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.

JRCT ID: jRCT2021240013

Registered date:27/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia
• Date of first enrollment: 04/07/2024
• Target sample size: 1
• Countries of recruitment: Argentina,Japan,Australia,Japan,Beugium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Czech Republic,Japan,France,Japan,Germany,Japan,Greece,Japan,Italy,Japan,South Korea,Japan,Malaysia,Japan,Mexico,Japan,Netherlands,Japan,Portugal,Japan,Russia,Japan,Saudi Arabia,Japan,Spain,Japan,Switzerland,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Sabatolimab (MBG453): Solution for intravenous infusion
Azacitidine: Solution for subcutaneous injection or intravenous infusion
Venetoclax: Tablet for oral administration
Patients will take sabatolimab 800 mg i.v./q4w and venetoclax 400 mg p.o. b.i.d. and azacitidine 75 mg/m2/d d1-7/q4w

Outcome(s)

• Primary Outcome: Frequency and severity of AEs and SAEs

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 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 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.

Exclude criteria

- 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 of 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.

Related Information

• Primary Sponsor: Yamauchi Kyosuke
• Secondary ID(s): NCT05201066