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NCT05656248 · FLOW

Participant flow

Study of CPX-351 (VYXEOS) in Individuals < 22 Years With Secondary Myeloid Neoplasms · Source last updated 2026-10-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    All eligible patients will receive up to 2 cycles of CPX-351 for remission induction. The CPX-351 dose for the first induction cycle is 100 units/m\^2 (corresponds to 44 mg/m\^2 daunorubicin and 100 mg/m\^2 cytarabine) on Days 1, 3 and 5. A second induction cycle at the same CPX-351 dose is administered on Days 1 and 3 for patients with CR/CRi but positive residual disease (MRD ≥0.1%) by flow cytometry. Patients attaining complete remission and MRD \< 0.1% could proceed to hematopoietic stem cell transplantation (HSCT). If HSCT cannot be performed within four weeks from the evaluation date (Day 22 of the first cycle), patients will receive a second course with lower doses of daunorubicin (29 mg/m\^2) and cytarabine (65 mg/m\^2).
    id
    FG000
    title
    CPX-351 (Vyxeos)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        25
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        25
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
All 25 patients with Secondary Myeloid Neoplasms (SMN) were eligible for the study.
recruitment Details
25 patients enrolled in St. Jude between 1/17/2023 and 7/24/2025.
Complete source fields
groups
  1. description
    All eligible patients will receive up to 2 cycles of CPX-351 for remission induction. The CPX-351 dose for the first induction cycle is 100 units/m\^2 (corresponds to 44 mg/m\^2 daunorubicin and 100 mg/m\^2 cytarabine) on Days 1, 3 and 5. A second induction cycle at the same CPX-351 dose is administered on Days 1 and 3 for patients with CR/CRi but positive residual disease (MRD ≥0.1%) by flow cytometry. Patients attaining complete remission and MRD \< 0.1% could proceed to hematopoietic stem cell transplantation (HSCT). If HSCT cannot be performed within four weeks from the evaluation date (Day 22 of the first cycle), patients will receive a second course with lower doses of daunorubicin (29 mg/m\^2) and cytarabine (65 mg/m\^2).
    id
    FG000
    title
    CPX-351 (Vyxeos)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        25
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        25
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
All 25 patients with Secondary Myeloid Neoplasms (SMN) were eligible for the study.
recruitment Details
25 patients enrolled in St. Jude between 1/17/2023 and 7/24/2025.

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Preserved source evidence · Not medical advice