deltatrials
Active Not Recruiting PHASE1 INTERVENTIONAL 1-arm NCT04190550

Testing the Addition of an Anti-cancer Drug, Navtemadlin, to the Usual Treatments (Cytarabine and Idarubicin) in Patients With Acute Myeloid Leukemia

A Phase 1b Study With Expansion Cohort of Escalating Doses of KRT-232 (AMG 232) Administered in Combination With Standard Induction Chemotherapy (Cytarabine and Idarubicin) in Newly Diagnosed Acute Myelogenous Leukemia (AML)

Sponsor: National Cancer Institute (NCI)

Conditions Acute Myeloid Leukemia Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Interventions Cytarabine Idarubicin Hydrochloride Navtemadlin
Updated 34 times since 2020 Last updated: Mar 12, 2026 Started: Feb 4, 2021 Primary completion: Jun 30, 2026 Completion: Jun 30, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and is currently ongoing. National Cancer Institute (NCI) leads this study, which shows 34 recorded versions since 2021 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~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 – ~Jan 2021 · 6 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Jan 2022 · 4 months · monthly snapshot~Jan 2022 – ~Mar 2022 · 59 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jul 2022 · 2 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 – ~May 2023 · 4 months · monthly snapshot~May 2023 – ~Nov 2023 · 6 months · monthly snapshot~Nov 2023 – ~Feb 2024 · 3 months · monthly snapshot~Feb 2024 – ~May 2024 · 3 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshot~Jan 2025 – ~Mar 2025 · 59 days · monthly snapshot~Mar 2025 – ~Jul 2025 · 4 months · monthly snapshot~Jul 2025 – ~Jan 2026 · 6 months · monthly snapshot~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshot~Feb 2026 – ~Mar 2026 · 28 days · monthly snapshot~Mar 2026 – present · 4 months · monthly snapshot

Change History

34 versions recorded

  1. Mar 2026 — Present [monthly]

    Active Not Recruiting PHASE1

  2. Feb 2026 — Mar 2026 [monthly]

    Active Not Recruiting PHASE1

  3. Jan 2026 — Feb 2026 [monthly]

    Active Not Recruiting PHASE1

  4. Jul 2025 — Jan 2026 [monthly]

    Active Not Recruiting PHASE1

  5. Mar 2025 — Jul 2025 [monthly]

    Active Not Recruiting PHASE1

▶ Show 29 earlier versions

  1. Jan 2025 — Mar 2025 [monthly]

    Active Not Recruiting PHASE1

  2. Sep 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1

  4. May 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1

  5. Feb 2024 — May 2024 [monthly]

    Active Not Recruiting PHASE1

  6. Nov 2023 — Feb 2024 [monthly]

    Active Not Recruiting PHASE1

  7. May 2023 — Nov 2023 [monthly]

    Active Not Recruiting PHASE1

    Status: Suspended → Active Not Recruiting

  8. Jan 2023 — May 2023 [monthly]

    Suspended PHASE1

    Status: Recruiting → Suspended

  9. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE1

  10. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE1

  11. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE1

  12. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE1

  13. May 2022 — Jul 2022 [monthly]

    Recruiting PHASE1

  14. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE1

  15. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE1

    Status: Suspended → Recruiting

  16. Jan 2022 — Mar 2022 [monthly]

    Suspended PHASE1

  17. Sep 2021 — Jan 2022 [monthly]

    Suspended PHASE1

    Status: Recruiting → Suspended

  18. May 2021 — Sep 2021 [monthly]

    Recruiting PHASE1

  19. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE1

  20. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE1

  21. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE1

  22. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE1

    Status: Not Yet Recruiting → Recruiting

  23. Jul 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE1

  24. Jun 2020 — Jul 2020 [monthly]

    Not Yet Recruiting PHASE1

  25. May 2020 — Jun 2020 [monthly]

    Not Yet Recruiting PHASE1

  26. Apr 2020 — May 2020 [monthly]

    Not Yet Recruiting PHASE1

  27. Mar 2020 — Apr 2020 [monthly]

    Not Yet Recruiting PHASE1

  28. Feb 2020 — Mar 2020 [monthly]

    Not Yet Recruiting PHASE1

  29. Jan 2020 — Feb 2020 [monthly]

    Not Yet Recruiting PHASE1

    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