# Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

> **NCT04266301** · PHASE3 · TERMINATED · sponsor: **Novartis Pharmaceuticals** · enrollment: 530 (actual)

## Conditions studied

- Myelodysplastic Syndromes
- Leukemia, Myelomonocytic, Chronic

## Interventions

- **DRUG:** Sabatolimab
- **DRUG:** Azacitidine
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT04266301
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2020-06-08
- **Primary completion:** 2024-10-02
- **Final completion:** 2024-10-02
- **Target enrollment:** 530 (ACTUAL)
- **Why stopped:** In December 2023, Novartis decided to terminate the sabatolimab clinical development program early after Phase II (MDS1) and Phase III (MDS2) studies failed to meet their primary objectives. The termination was not due to safety concerns.
- **Last updated:** 2026-01-13


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04266301

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04266301, "Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT04266301. Licensed CC0.

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