deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT02610777

An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML)

A Phase 2, Randomized, Controlled, Open-Label, Clinical Study of the Efficacy and Safety of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myelogenous Leukemia

Sponsor: Millennium Pharmaceuticals, Inc.

Updated 21 times since 2017 Last updated: Aug 24, 2022 Started: Apr 14, 2016 Primary completion: Sep 4, 2019 Completion: Jul 23, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Leukemia, Myeloid, Acute and Leukemia, Myelomonocytic, Chronic and is currently completed. Millennium Pharmaceuticals, Inc. leads this study, which shows 21 recorded versions since 2016 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshot~Jun 2017 – ~Jul 2017 · 30 days · monthly snapshot~Jul 2017 – ~Aug 2017 · 31 days · monthly snapshot~Aug 2017 – ~Jan 2018 · 5 months · monthly snapshot~Jan 2018 – ~May 2018 · 4 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Dec 2019 · 12 months · monthly snapshot~Dec 2019 – ~Oct 2020 · 10 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Sep 2021 · 7 months · monthly snapshot~Sep 2021 – ~Jul 2022 · 10 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Jul 2024 · 22 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

21 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Sep 2022 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jul 2022 — Sep 2022 [monthly]

    Completed PHASE2

Show 16 earlier versions
  1. Sep 2021 — Jul 2022 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  2. Feb 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE2

  3. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE2

  4. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

  5. Dec 2019 — Oct 2020 [monthly]

    Active Not Recruiting PHASE2

  6. Dec 2018 — Dec 2019 [monthly]

    Active Not Recruiting PHASE2

  7. Nov 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE2

  8. Oct 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE2

  9. Jun 2018 — Oct 2018 [monthly]

    Active Not Recruiting PHASE2

  10. May 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2

  11. Jan 2018 — May 2018 [monthly]

    Active Not Recruiting PHASE2

  12. Aug 2017 — Jan 2018 [monthly]

    Active Not Recruiting PHASE2

  13. Jul 2017 — Aug 2017 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  14. Jun 2017 — Jul 2017 [monthly]

    Recruiting PHASE2

  15. Feb 2017 — Jun 2017 [monthly]

    Recruiting PHASE2

  16. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Apr 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Millennium Pharmaceuticals, Inc.
Data source: Takeda

For direct contact, visit the study record on ClinicalTrials.gov .