deltatrials
Recruiting PHASE2 INTERVENTIONAL 1-arm NCT04493164

CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Phase II Investigator Sponsored Study of CPX-351 in Combination With Ivosidenib for Patients With IDH1 Mutated Acute Myeloid Leukemia or High-Risk MDS

Sponsor: M.D. Anderson Cancer Center

Conditions Acute Myeloid Leukemia With Gene Mutations Myelodysplastic Syndrome Myeloproliferative Neoplasm Recurrent Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia
Interventions Ivosidenib Liposome-encapsulated Daunorubicin-Cytarabine
Updated 18 times since 2020 Last updated: Nov 20, 2025 Started: Dec 30, 2020 Primary completion: Jun 1, 2026 Completion: Jun 1, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Acute Myeloid Leukemia With Gene Mutations and Myelodysplastic Syndrome, this trial is actively recruiting participants. The trial is conducted by M.D. Anderson Cancer Center and has accumulated 18 data snapshots since 2020. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Jul 2022 · 15 months · monthly snapshot~Jul 2022 – ~Feb 2023 · 7 months · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Sep 2023 · 6 months · monthly snapshot~Sep 2023 – ~Dec 2023 · 3 months · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Apr 2024 · 3 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~May 2025 · 6 months · monthly snapshot~May 2025 – ~Jul 2025 · 2 months · monthly snapshot~Jul 2025 – ~Dec 2025 · 5 months · monthly snapshot~Dec 2025 – present · 9 months · monthly snapshot

Change History

18 versions recorded

  1. Dec 2025 — Present [monthly]

    Recruiting PHASE2

  2. Jul 2025 — Dec 2025 [monthly]

    Recruiting PHASE2

  3. May 2025 — Jul 2025 [monthly]

    Recruiting PHASE2

  4. Nov 2024 — May 2025 [monthly]

    Recruiting PHASE2

  5. Oct 2024 — Nov 2024 [monthly]

    Recruiting PHASE2

▶ Show 13 earlier versions

  1. Sep 2024 — Oct 2024 [monthly]

    Recruiting PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE2

  3. Apr 2024 — Jul 2024 [monthly]

    Recruiting PHASE2

  4. Jan 2024 — Apr 2024 [monthly]

    Recruiting PHASE2

  5. Dec 2023 — Jan 2024 [monthly]

    Recruiting PHASE2

  6. Sep 2023 — Dec 2023 [monthly]

    Recruiting PHASE2

  7. Mar 2023 — Sep 2023 [monthly]

    Recruiting PHASE2

  8. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE2

  9. Jul 2022 — Feb 2023 [monthly]

    Recruiting PHASE2

  10. Apr 2021 — Jul 2022 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  11. Jan 2021 — Apr 2021 [monthly]

    Not Yet Recruiting PHASE2

  12. Sep 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE2

  13. Aug 2020 — Sep 2020 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

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