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Phase IB/II of CPX-351 for Relapse Prevention in AML

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Dec 2025 to Dec 2026 Site contacts updated at 1 of 3 sites · Eligibility criteria expanded, about 5 wordsv18 Show 2 more changesShow less
    • Site contacts updated at 1 of 3 sites
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary and study completion dates: Aug 2025 to Dec 2025 Site contacts updated at 2 of 3 sitesv17 Show 1 more changeShow less
    • Site contacts updated at 2 of 3 sites
  3. Site contacts updated at 1 of 3 sitesv16
  4. Primary and study completion dates: Aug 2024 to Aug 2025v15
  5. Site contacts updated at 1 of 3 sitesv14
Show 12 earlier versionsHide 12 earlier versions
  1. Primary and study completion dates: Aug 2023 to Aug 2024 Study sites: 2 to 3v13 Show 1 more changeShow less
    • Study sites: 2 to 3
  2. Start date changed from estimate of May 2023 to May 22, 2023v12
  3. Start date: Apr 2023 to May 2023v11
  4. Start date: Feb 2023 to Apr 2023 Study sites: 1 to 2v10 Show 1 more changeShow less
    • Study sites: 1 to 2
  5. Start date: Dec 2022 to Feb 2023v9
  6. Start date: Oct 2022 to Dec 2022v8
  7. Start date: Jul 2022 to Oct 2022v7
  8. Start date: Mar 2022 to Jul 2022v6
  9. Start date: Jan 2022 to Mar 2022v5
  10. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v4 Show 1 more changeShow less
    • Study sites: 0 to 1
  11. Start date: Oct 2021 to Jan 2022v3
  12. Start date: Aug 2021 to Oct 2021v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 IB/II study with a 3+3 dose de-escalation study design. Patients will continue maintenance treatment with CPX-351 for 6 cycles on D1 and D3, as long as patient remains in CR. The dose de-escalation will be one dose given on D1 only, every 28 days pending toxicity. The maximum tolerated dose will be used for the phase II expansion portion of the study.
Trial Details
NCT Number NCT04990102
Lead Sponsor Georgetown University
Collaborators: Jazz Pharmaceuticals, National Heart, Lung, and Blood Institute (NHLBI)
Conditions Acute Myeloid Leukemia (AML) in Remission
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov