deltatrials
Completed PHASE2/PHASE3 INTERVENTIONAL 4-arm NCT03092674

Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

A Randomized Phase II/III Trial of Novel Therapeutics Versus Azacitidine in Newly Diagnosed Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS), Age 60 or Older LEAP: Less-Intense AML Platform Trial

Sponsor: National Cancer Institute (NCI)

Conditions Acute Myeloid Leukemia Myelodysplastic Syndrome Myelodysplastic Syndrome/Acute Myeloid Leukemia
Interventions Azacitidine Cytarabine Decitabine Laboratory Biomarker Analysis Midostaurin Nivolumab
Updated 60 times since 2017 Last updated: Jan 15, 2025 Started: Feb 2, 2018 Primary completion: Aug 1, 2023 Completion: Jun 26, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2/PHASE3 clinical study on Acute Myeloid Leukemia and Myelodysplastic Syndrome, this trial is completed. The trial is conducted by National Cancer Institute (NCI) and has accumulated 60 data snapshots since 2018. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~May 2017 – ~Oct 2017 · 5 months · monthly snapshot~Oct 2017 – ~Jan 2018 · 3 months · monthly snapshot~Jan 2018 – ~Feb 2018 · 31 days · monthly snapshot~Feb 2018 – ~Mar 2018 · 28 days · monthly snapshot~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshot~Apr 2018 – ~May 2018 · 30 days · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · 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 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Oct 2020 · 3 months · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Jun 2021 · 4 months · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Feb 2022 · 4 months · monthly snapshot~Feb 2022 – ~May 2022 · 3 months · monthly snapshot~May 2022 – ~Jul 2022 · 2 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Feb 2023 · 5 months · 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 – ~Aug 2023 · 2 months · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Dec 2023 · 3 months · monthly snapshot~Dec 2023 – ~Jul 2024 · 7 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Dec 2024 · 30 days · monthly snapshot~Dec 2024 – ~Jan 2025 · 31 days · monthly snapshot~Jan 2025 – ~Feb 2025 · 31 days · monthly snapshot~Feb 2025 – ~Sep 2025 · 7 months · monthly snapshot~Sep 2025 – present · 8 months · monthly snapshot

Change History

60 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2/PHASE3

  2. Feb 2025 — Sep 2025 [monthly]

    Completed PHASE2/PHASE3

    Status: Active Not Recruiting → Completed

  3. Jan 2025 — Feb 2025 [monthly]

    Active Not Recruiting PHASE2/PHASE3

  4. Dec 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE2/PHASE3

  5. Nov 2024 — Dec 2024 [monthly]

    Active Not Recruiting PHASE2/PHASE3

▶ Show 55 earlier versions

  1. Oct 2024 — Nov 2024 [monthly]

    Active Not Recruiting PHASE2/PHASE3

  2. Sep 2024 — Oct 2024 [monthly]

    Active Not Recruiting PHASE2/PHASE3

  3. Aug 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE2/PHASE3

  4. Jul 2024 — Aug 2024 [monthly]

    Active Not Recruiting PHASE2/PHASE3

    Phase: PHASE2_PHASE3 → PHASE2/PHASE3

  5. Dec 2023 — Jul 2024 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  6. Sep 2023 — Dec 2023 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  7. Aug 2023 — Sep 2023 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  8. Jun 2023 — Aug 2023 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  9. Apr 2023 — Jun 2023 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  10. Mar 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  11. Feb 2023 — Mar 2023 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  12. Sep 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  13. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  14. May 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  15. Feb 2022 — May 2022 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  16. Oct 2021 — Feb 2022 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  17. Sep 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  18. Jun 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  19. Feb 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  20. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  21. Nov 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  22. Oct 2020 — Nov 2020 [monthly]

    Active Not Recruiting PHASE2_PHASE3

    Status: Suspended → Active Not Recruiting

  23. Jul 2020 — Oct 2020 [monthly]

    Suspended PHASE2_PHASE3

  24. Jun 2020 — Jul 2020 [monthly]

    Suspended PHASE2_PHASE3

  25. May 2020 — Jun 2020 [monthly]

    Suspended PHASE2_PHASE3

  26. Apr 2020 — May 2020 [monthly]

    Suspended PHASE2_PHASE3

  27. Mar 2020 — Apr 2020 [monthly]

    Suspended PHASE2_PHASE3

  28. Feb 2020 — Mar 2020 [monthly]

    Suspended PHASE2_PHASE3

  29. Jan 2020 — Feb 2020 [monthly]

    Suspended PHASE2_PHASE3

  30. Dec 2019 — Jan 2020 [monthly]

    Suspended PHASE2_PHASE3

  31. Nov 2019 — Dec 2019 [monthly]

    Suspended PHASE2_PHASE3

  32. Oct 2019 — Nov 2019 [monthly]

    Suspended PHASE2_PHASE3

  33. Sep 2019 — Oct 2019 [monthly]

    Suspended PHASE2_PHASE3

  34. Aug 2019 — Sep 2019 [monthly]

    Suspended PHASE2_PHASE3

  35. Jul 2019 — Aug 2019 [monthly]

    Suspended PHASE2_PHASE3

  36. Jun 2019 — Jul 2019 [monthly]

    Suspended PHASE2_PHASE3

  37. May 2019 — Jun 2019 [monthly]

    Suspended PHASE2_PHASE3

  38. Apr 2019 — May 2019 [monthly]

    Suspended PHASE2_PHASE3

  39. Mar 2019 — Apr 2019 [monthly]

    Suspended PHASE2_PHASE3

  40. Feb 2019 — Mar 2019 [monthly]

    Suspended PHASE2_PHASE3

  41. Jan 2019 — Feb 2019 [monthly]

    Suspended PHASE2_PHASE3

  42. Dec 2018 — Jan 2019 [monthly]

    Suspended PHASE2_PHASE3

    Status: Recruiting → Suspended

  43. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE2_PHASE3

  44. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE2_PHASE3

  45. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE2_PHASE3

  46. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE2_PHASE3

  47. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE2_PHASE3

  48. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE2_PHASE3

  49. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE2_PHASE3

  50. Apr 2018 — May 2018 [monthly]

    Recruiting PHASE2_PHASE3

  51. Mar 2018 — Apr 2018 [monthly]

    Recruiting PHASE2_PHASE3

  52. Feb 2018 — Mar 2018 [monthly]

    Recruiting PHASE2_PHASE3

  53. Jan 2018 — Feb 2018 [monthly]

    Recruiting PHASE2_PHASE3

    Status: Not Yet Recruiting → Recruiting

  54. Oct 2017 — Jan 2018 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

  55. May 2017 — Oct 2017 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
Data source: National Cancer Institute (NCI)

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

Study Locations

Aberdeen, United States , Abington, United States , Albuquerque, United States , Allentown, United States , Ames, United States , Anaconda, United States , Anchorage, United States , Ann Arbor, United States , Antioch, United States , Ashland, United States and 316 more locations