Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04269213 | CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old | PHASE2 | ACTIVE NOT_RECRUITING | 21 | — | — | Jul 29, 2021 | Jan 29, 2027 | Dec 23, 2025 | 4 | United States |
Defined by the International Working Group Criteria. Will be summarized using frequencies and relative frequencies.
| Arm | Type | Description |
|---|---|---|
| Treatment (CPX-351) | EXPERIMENTAL | INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Liposome-encapsulated Daunorubicin-Cytarabine | DRUG | Given IV |
Inclusion Criteria: * Newly diagnosed: * Therapy-related acute myeloid leukemia (AML) * AML with antecedent myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) * AML with MDS-related changes (as per World Health Organization \[WHO\]) * Have an Eastern Cooperative Oncolog...