# Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)

> **NCT03268954** · PHASE3 · COMPLETED · sponsor: **Takeda** · enrollment: 454 (actual)

## Conditions studied

- Myelodysplastic Syndrome
- Leukemia, Myelomonocytic, Chronic
- Leukemia, Myeloid, Acute

## Interventions

- **DRUG:** Azacitidine
- **DRUG:** Pevonedistat

## Key facts

- **NCT ID:** NCT03268954
- **Lead sponsor:** Takeda
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2017-11-28
- **Primary completion:** 2021-05-28
- **Final completion:** 2024-10-14
- **Target enrollment:** 454 (ACTUAL)
- **Last updated:** 2025-10-29

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03268954

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03268954, "Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT03268954. Licensed CC0.

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