Study of CPX-351 (VYXEOS) in Individuals < 22 Years With Secondary Myeloid Neoplasms

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary endpoint reworded 3 of 3 changed
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Record History

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  1. Primary endpoint(s) modified Show 6 more changesShow less
    • Results posted: Oct 15, 2026
    • Lead sponsor: St. Jude Children's Research Hospital to St. Jude Children's Research Hospital
    • Eligibility criteria expanded, about 53 words
    • Secondary endpoints revised (4)
    • Site details revised
    • Study description expanded, about 3 words
  2. Secondary endpoints: 5 to 4
    • Study description shortened, about 17 words
    v12
  3. Re-verified, no change to tracked fieldsv11
  4. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Aug 2025 to Aug 28, 2025
    • Site details revised
    v10
  5. Eligibility criteria revisedv9
Show 7 earlier versionsHide 7 earlier versions
  1. Re-verified, no change to tracked fieldsv8
  2. Eligibility criteria expanded, about 51 words
    • Study description expanded, about 2 words
    v7
  3. Eligibility criteria revisedv6
  4. Interventions: CPX-351 (Drug), MHA (Drug) to Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), CPX-351 (Drug), MHA (Drug)
    • Eligibility criteria expanded, about 7 words
    • Study description expanded, about 43 words
    v5
  5. Eligibility criteria expanded, about 1 wordv4
  6. Start date changed from estimate of Jan 2023 to Jan 17, 2023v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  1. Study First Submitted
  • 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 learn the effects of treatment with an investigational drug, CPX-351 in patients with secondary myeloid neoplasms (SMNs).
Trial Details
NCT Number NCT05656248
Lead Sponsor St. Jude Children's Research Hospital
Collaborators: Jazz Pharmaceuticals
Conditions
(from sponsor)		 Myeloid Neoplasm
Related terms Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Juvenile, Myelodysplastic Syndromes
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov