An open-label, multicenter, 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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515281-14-00

Acronym

CMBG453B12206B

Enrollment

Registered

2024-09-16

Start date

2023-02-13

Completion date

Unknown

Last updated

2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intermediate, high or very high risk MDS in adult patients chronic Myelomonocytic Leukemia - 2 (CMML-2) Acute Myeloid Leukemia (AML) in adult patients unfit for chemotherapy

Brief summary

Frequency and severity of AEs and SAEs

Detailed description

Duration of exposure to sabatolimab

Interventions

DRUGVENETOCLAX

DRUGAZACITIDINE

DRUGMBG453

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Frequency and severity of AEs and SAEs	—

Secondary

Measure	Time frame
Duration of exposure to sabatolimab	—

Countries

Czechia, France, Germany, Greece, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026