deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT01566695

The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)

A Phase 3, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Subjects With Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia Due to IPSS Lower-risk Myelodysplastic Syndromes.

Sponsor: Celgene

Updated 35 times since 2017 Last updated: Dec 13, 2024 Started: Apr 26, 2013 Primary completion: Jan 25, 2019 Completion: Dec 21, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01566695, this PHASE3 trial focuses on Myelodysplastic Syndrome and remains completed. Sponsored by Celgene, it has been updated 35 times since 2013, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~Jun 2017 · 2 months · monthly snapshot~Jun 2017 – ~Sep 2017 · 3 months · monthly snapshot~Sep 2017 – ~Oct 2017 · 30 days · monthly snapshot~Oct 2017 – ~Nov 2017 · 31 days · monthly snapshot~Nov 2017 – ~Dec 2017 · 30 days · monthly snapshot~Dec 2017 – ~Mar 2018 · 3 months · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Feb 2019 · 5 months · monthly snapshot~Feb 2019 – ~May 2019 · 3 months · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Nov 2019 · 3 months · monthly snapshot~Nov 2019 – ~Mar 2020 · 4 months · monthly snapshot~Mar 2020 – ~Jun 2020 · 3 months · monthly snapshot~Jun 2020 – ~Jan 2021 · 7 months · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Feb 2022 · 9 months · monthly snapshot~Feb 2022 – ~Jul 2022 · 5 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Jan 2023 · 4 months · monthly snapshot~Jan 2023 – ~Mar 2023 · 59 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~Jul 2023 · 3 months · monthly snapshot~Jul 2023 – ~Oct 2023 · 3 months · monthly snapshot~Oct 2023 – ~Dec 2023 · 2 months · monthly snapshot~Dec 2023 – ~Feb 2024 · 2 months · monthly snapshot~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshot~Feb 2025 – ~Sep 2025 · 7 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

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

    Completed PHASE3

  2. Feb 2025 — Sep 2025 [monthly]

    Completed PHASE3

  3. Sep 2024 — Feb 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Feb 2024 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

Show 30 earlier versions
  1. Dec 2023 — Feb 2024 [monthly]

    Active Not Recruiting PHASE3

  2. Oct 2023 — Dec 2023 [monthly]

    Active Not Recruiting PHASE3

  3. Jul 2023 — Oct 2023 [monthly]

    Active Not Recruiting PHASE3

  4. Apr 2023 — Jul 2023 [monthly]

    Active Not Recruiting PHASE3

  5. Mar 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE3

  6. Jan 2023 — Mar 2023 [monthly]

    Active Not Recruiting PHASE3

  7. Sep 2022 — Jan 2023 [monthly]

    Active Not Recruiting PHASE3

  8. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

  9. Feb 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE3

  10. May 2021 — Feb 2022 [monthly]

    Active Not Recruiting PHASE3

  11. Jan 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE3

  12. Jun 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  13. Mar 2020 — Jun 2020 [monthly]

    Active Not Recruiting PHASE3

  14. Nov 2019 — Mar 2020 [monthly]

    Active Not Recruiting PHASE3

  15. Aug 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE3

  16. Jul 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE3

  17. Jun 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE3

  18. May 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE3

  19. Feb 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE3

  20. Sep 2018 — Feb 2019 [monthly]

    Active Not Recruiting PHASE3

  21. Jun 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE3

  22. Mar 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  23. Dec 2017 — Mar 2018 [monthly]

    Recruiting PHASE3

  24. Nov 2017 — Dec 2017 [monthly]

    Recruiting PHASE3

  25. Oct 2017 — Nov 2017 [monthly]

    Recruiting PHASE3

  26. Sep 2017 — Oct 2017 [monthly]

    Recruiting PHASE3

  27. Jun 2017 — Sep 2017 [monthly]

    Recruiting PHASE3

  28. Apr 2017 — Jun 2017 [monthly]

    Recruiting PHASE3

  29. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE3

  30. 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 .