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CPX-351 as a Novel Approach for the Treatment of Older Patients With AML and MDS

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

Record History

  1. Primary completion date changed from estimate of Oct 10, 2025 to Jan 19, 2026
    • Study completion date: Oct 10, 2026 to Jan 19, 2027
    v11
  2. Primary completion date: Sep 2025 to Oct 10, 2025
    • Study completion date: Jun 1, 2027 to Oct 10, 2026
    v10
  3. Primary completion date: Jun 1, 2025 to Sep 2025v9
  4. Primary completion date: Dec 1, 2024 to Jun 1, 2025
    • Study completion date: Dec 1, 2026 to Jun 1, 2027
    v8
  5. Primary completion date: Jun 1, 2024 to Dec 1, 2024
    • Study completion date: Jun 1, 2026 to Dec 1, 2026
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Dec 2023 to Jun 1, 2024
    • Study completion date: Dec 2025 to Jun 1, 2026
    v6
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 20 to confirmed 13
    • Site details revised
    v5
  3. 2 versions Re-verified since Jan 25, 2022, no change to tracked fieldsv3-v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2021 to Jan 14, 2021
    • Site details revised
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to evaluate how effective lower doses of CPX-351 are in older participants with relapsed/refractory acute myeloid leukemia (AML) who are not eligible to receive intensive chemotherapy and in participants with myelodysplastic syndromes (MDS) after Hypomethylating Agents (HMA) failure.
Trial Details
NCT Number NCT04668885
Lead Sponsor Case Comprehensive Cancer Center
Conditions
(from sponsor)		 Refractory Acute Myeloid Leukemia, Relapsed Acute Myelomonocytic Leukemia, Myelodysplastic Syndromes
Related terms Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Acute, Myelodysplastic Syndromes
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov