# 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)

Source: https://onco.cc/trials/nct03268954/  
OnCo record `nct03268954` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Azacitidine and Pevonedistat in Leukaemia, run by Takeda, completed.

## Summary

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) is a phase 3 interventional study registered as NCT03268954 by Takeda, with 454 participants recorded, started 2017-11-28 and reaching its primary completion in 2021-05-28. Interventions recorded: Azacitidine, Pevonedistat. Conditions recorded: Myelodysplastic Syndrome, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute.

Linked to the drug Pevonedistat because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-09-22
- Tags: pipeline; ctgov-ingest
- Registry id: NCT03268954
- Phase: 3
- Setting: A Phase 3, Randomized, Controlled, Open-label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia
- Sponsor: Takeda
- Enrolled: 454

## Sources

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

## Connected records

- cancers: [Leukaemia (all types)](https://onco.cc/cancers/leukaemia/)
- drugs: [Azacitidine](https://onco.cc/drugs/azacitidine/), [Pevonedistat](https://onco.cc/drugs/pevonedistat/)
- companies: [Takeda](https://onco.cc/companies/takeda/)

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