NCT05656248 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- 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
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 25
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 25
- type
- COMPLETED
- achievements
- 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
- 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
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 25
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 25
- type
- COMPLETED
- achievements
- 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
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