deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT01757535

Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission (QUAZAR AML-001)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission

Sponsor: Celgene

Conditions Leukemia, Myeloid, Acute
Interventions Oral Azacitidine Placebo
Updated 34 times since 2017 Last updated: Jun 17, 2025 Started: Apr 24, 2013 Primary completion: Jul 15, 2019 Completion: Jun 18, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Leukemia, Myeloid, Acute and is currently completed. Celgene leads this study, which shows 34 recorded versions since 2013 — 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 – ~Dec 2017 · 6 months · monthly snapshot~Dec 2017 – ~Jan 2018 · 31 days · monthly snapshot~Jan 2018 – ~Mar 2018 · 59 days · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~May 2019 · 6 months · monthly snapshot~May 2019 – ~Aug 2019 · 3 months · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Nov 2019 · 2 months · monthly snapshot~Nov 2019 – ~Dec 2020 · 13 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Jun 2021 · 5 months · monthly snapshot~Jun 2021 – ~Jan 2022 · 7 months · monthly snapshot~Jan 2022 – ~Jul 2022 · 6 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~Jun 2023 · 2 months · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Feb 2024 · 6 months · monthly snapshot~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Aug 2025 · 11 months · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – present · 11 months · monthly snapshot

Change History

34 versions recorded

  1. Oct 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Oct 2025 [monthly]

    Completed PHASE3

  3. Aug 2025 — Sep 2025 [monthly]

    Completed PHASE3

  4. Sep 2024 — Aug 2025 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  5. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

▶ Show 29 earlier versions

  1. Feb 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

  2. Aug 2023 — Feb 2024 [monthly]

    Active Not Recruiting PHASE3

  3. Jul 2023 — Aug 2023 [monthly]

    Active Not Recruiting PHASE3

  4. Jun 2023 — Jul 2023 [monthly]

    Active Not Recruiting PHASE3

  5. Apr 2023 — Jun 2023 [monthly]

    Active Not Recruiting PHASE3

  6. Mar 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE3

  7. Feb 2023 — Mar 2023 [monthly]

    Active Not Recruiting PHASE3

  8. Jan 2023 — Feb 2023 [monthly]

    Active Not Recruiting PHASE3

  9. Dec 2022 — Jan 2023 [monthly]

    Active Not Recruiting PHASE3

  10. Nov 2022 — Dec 2022 [monthly]

    Active Not Recruiting PHASE3

  11. Sep 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE3

  12. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

  13. Jan 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE3

  14. Jun 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE3

  15. Jan 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE3

  16. Dec 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  17. Nov 2019 — Dec 2020 [monthly]

    Active Not Recruiting PHASE3

  18. Sep 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE3

  19. Aug 2019 — Sep 2019 [monthly]

    Active Not Recruiting PHASE3

  20. May 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE3

  21. Nov 2018 — May 2019 [monthly]

    Active Not Recruiting PHASE3

  22. Oct 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE3

  23. Jun 2018 — Oct 2018 [monthly]

    Active Not Recruiting PHASE3

  24. Mar 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  25. Jan 2018 — Mar 2018 [monthly]

    Active Not Recruiting PHASE3

  26. Dec 2017 — Jan 2018 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  27. Jun 2017 — Dec 2017 [monthly]

    Recruiting PHASE3

  28. Feb 2017 — Jun 2017 [monthly]

    Recruiting PHASE3

  29. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Apr 2013

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Celgene
Data source: Celgene

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

Study Locations

A Coruña, Spain , Adelaide, Australia , Alessandria, Italy , Amiens, France , Ankara, Turkey (Türkiye) , Argenteuil, France , Badalona (Barcelona), Spain , Barcelona, Spain , Bari, Italy , Bedford Park, Australia and 176 more locations