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CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints revised (6)v12 See this version in full on ClinicalTrials.gov ↗
  2. Results first posted: Mar 6, 2026 Secondary endpoints revised (6) · Primary endpoint revisedv11 Show 2 more changesShow less
    • Secondary endpoints revised (6)
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date changed from estimate of Jun 30, 2025 to Jun 30, 2024v10
  4. Primary completion date: Jun 1, 2024 to Jun 30, 2025 Trial status: Recruiting to Active, Not Recruiting · Completion date: Sep 30, 2025 to Jun 30, 2027 · Site details revised at 4 of 4 sitesv9 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Sep 30, 2025 to Jun 30, 2027
    • Site details revised at 4 of 4 sites
  5. Study sites: 3 to 4 Primary completion date: Mar 31, 2024 to Jun 1, 2024v8 Show 1 more changeShow less
    • Primary completion date: Mar 31, 2024 to Jun 1, 2024
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Mar 31, 2023 to Mar 31, 2024 Completion date: Sep 30, 2023 to Sep 30, 2025v7 Show 1 more changeShow less
    • Completion date: Sep 30, 2023 to Sep 30, 2025
  2. Primary completion date: Sep 30, 2021 to Mar 31, 2023 Completion date: Sep 30, 2022 to Sep 30, 2023 · Study sites revised (3)v6 Show 2 more changesShow less
    • Completion date: Sep 30, 2022 to Sep 30, 2023
    • Study sites revised (3)

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 2 to 3v5
  4. Primary completion date: Dec 31, 2020 to Sep 30, 2021 Completion date: Dec 31, 2021 to Sep 30, 2022 · Eligibility criteria expanded, about 92 wordsv4 Show 2 more changesShow less
    • Completion date: Dec 31, 2021 to Sep 30, 2022
    • Eligibility criteria expanded, about 92 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 1 to 2 Eligibility criteria expanded, about 45 wordsv3 Show 1 more changeShow less
    • Eligibility criteria expanded, about 45 words

    See this version in full on ClinicalTrials.gov ↗

  6. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 1, 2020 to Feb 19, 2020 · Eligibility criteria shortened, about 19 words · Site details revisedv2 Show 3 more changesShow less
    • Start date changed from estimate of Feb 1, 2020 to Feb 19, 2020
    • Eligibility criteria shortened, about 19 words
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a phase 2 single-arm, open-label clinical trial determining efficacy of CPX-351 in combination with Glasdegib in subjects with Acute Myelogenous Leukemia with myelodysplastic syndrome related changes or therapy-related acute myeloid leukemia.
Trial Details
NCT Number NCT04231851
Lead Sponsor University of California, Irvine
Collaborators: Jazz Pharmaceuticals, Pfizer
Conditions Acute Myelogenous Leukemia (AML) Due to Therapy, Acute Myeloid Leukemia With Myelodysplasia-Related Changes
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov