deltatrials
Recruiting PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT03471260

Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies

Phase Ib/II Investigator Initiated Study of the IDH1-Mutant Inhibitor Ivosidenib (AG120) With the BCL2 Inhibitor Venetoclax +/- Azacitidine in IDH1-Mutated Hematologic Malignancies

Sponsor: M.D. Anderson Cancer Center

Conditions Acute Myeloid Leukemia Hematopoietic and Lymphoid System Neoplasm Myelodysplastic Syndrome Myeloproliferative Neoplasm Recurrent Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia
Interventions Azacitidine Ivosidenib Venetoclax
Updated 34 times since 2018 Last updated: Mar 10, 2026 Started: Mar 19, 2018 Primary completion: Sep 30, 2027 Completion: Sep 30, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03471260, this PHASE1/PHASE2 trial focuses on Acute Myeloid Leukemia and Hematopoietic and Lymphoid System Neoplasm and remains actively recruiting participants. Sponsored by M.D. Anderson Cancer Center, it has been updated 34 times since 2018, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Dec 2018 · 4 months · monthly snapshot~Dec 2018 – ~Feb 2019 · 2 months · monthly snapshot~Feb 2019 – ~Jun 2019 · 4 months · monthly snapshot~Jun 2019 – ~Jan 2020 · 7 months · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Jun 2020 · 4 months · monthly snapshot~Jun 2020 – ~Sep 2020 · 3 months · monthly snapshot~Sep 2020 – ~Nov 2020 · 2 months · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~Jun 2021 · 2 months · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Sep 2022 · 12 months · monthly snapshot~Sep 2022 – ~Jan 2023 · 4 months · monthly snapshot~Jan 2023 – ~Sep 2023 · 8 months · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Dec 2023 · 2 months · monthly snapshot~Dec 2023 – ~Mar 2024 · 3 months · monthly snapshot~Mar 2024 – ~Jun 2024 · 3 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshot~Feb 2025 – ~May 2025 · 3 months · monthly snapshot~May 2025 – ~Aug 2025 · 3 months · monthly snapshot~Aug 2025 – ~Oct 2025 · 2 months · monthly snapshot~Oct 2025 – ~Nov 2025 · 31 days · monthly snapshot~Nov 2025 – ~Mar 2026 · 4 months · monthly snapshot~Mar 2026 – present · 6 months · monthly snapshot

Change History

34 versions recorded

  1. Mar 2026 — Present [monthly]

    Recruiting PHASE1/PHASE2

  2. Nov 2025 — Mar 2026 [monthly]

    Recruiting PHASE1/PHASE2

  3. Oct 2025 — Nov 2025 [monthly]

    Recruiting PHASE1/PHASE2

  4. Aug 2025 — Oct 2025 [monthly]

    Recruiting PHASE1/PHASE2

  5. May 2025 — Aug 2025 [monthly]

    Recruiting PHASE1/PHASE2

▶ Show 29 earlier versions

  1. Feb 2025 — May 2025 [monthly]

    Recruiting PHASE1/PHASE2

  2. Sep 2024 — Feb 2025 [monthly]

    Recruiting PHASE1/PHASE2

  3. Aug 2024 — Sep 2024 [monthly]

    Recruiting PHASE1/PHASE2

  4. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  5. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

  6. Mar 2024 — Jun 2024 [monthly]

    Recruiting PHASE1_PHASE2

  7. Dec 2023 — Mar 2024 [monthly]

    Recruiting PHASE1_PHASE2

  8. Oct 2023 — Dec 2023 [monthly]

    Recruiting PHASE1_PHASE2

  9. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE1_PHASE2

  10. Jan 2023 — Sep 2023 [monthly]

    Recruiting PHASE1_PHASE2

  11. Sep 2022 — Jan 2023 [monthly]

    Recruiting PHASE1_PHASE2

  12. Sep 2021 — Sep 2022 [monthly]

    Recruiting PHASE1_PHASE2

  13. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE1_PHASE2

  14. Apr 2021 — Jun 2021 [monthly]

    Recruiting PHASE1_PHASE2

  15. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE1_PHASE2

  16. Jan 2021 — Mar 2021 [monthly]

    Recruiting PHASE1_PHASE2

  17. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

  18. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE1_PHASE2

  19. Sep 2020 — Nov 2020 [monthly]

    Recruiting PHASE1_PHASE2

  20. Jun 2020 — Sep 2020 [monthly]

    Recruiting PHASE1_PHASE2

  21. Feb 2020 — Jun 2020 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Active Not Recruiting → Recruiting

  22. Jan 2020 — Feb 2020 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  23. Jun 2019 — Jan 2020 [monthly]

    Recruiting PHASE1_PHASE2

  24. Feb 2019 — Jun 2019 [monthly]

    Recruiting PHASE1_PHASE2

  25. Dec 2018 — Feb 2019 [monthly]

    Recruiting PHASE1_PHASE2

  26. Aug 2018 — Dec 2018 [monthly]

    Recruiting PHASE1_PHASE2

  27. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE1_PHASE2

  28. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE1_PHASE2

  29. Apr 2018 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Mar 2018

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • M.D. Anderson Cancer Center
Data source: M.D. Anderson Cancer Center

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

Study Locations