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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04801797 | Venetoclax + Azacitidine vs. Induction Chemotherapy in AML | PHASE2 | RECRUITING | 172 | — | — | May 20, 2021 | Jan 1, 2028 | Nov 14, 2025 | 9 | United States |
Primary endpoint is event-free-survival of patients treated with venetoclax and azacitidine compared to patients treated with standard induction with either 7+3 regimen or liposomal daunorubicin and cytarabine Events are described in the protocol and will include * Progressive Disease as defined above * Any change in therapy due to leukemic persistence. * Transition to hospice * Relapse following CR, CRi, or CRh * Any death Assessments of differences in EFS between the randomized arms will be made with the log-rank test; modeling will employ the Cox proportional hazards model. We also plan to assess the difference in estimated EFS at one year, using Kaplan-Meier estimates with standard deviation calculated by Greenwood's formula. EFS will be assessed using the Kaplan-Meier method. EFS will be assessed with the log-rank test, and cox proportional hazards model when appropriate.
| Arm | Type | Description |
|---|---|---|
| Standard of Care (Conventional Induction) | EXPERIMENTAL | Randomized participants will receive cytarabine and idarubicin \[or daunorubicin) per standard of care as follows: Induction: cytarabine on days 1-7 and idarubicin (or daunorubicin) on days 1-3 of induction. Second Induction (if needed): Cytarabine on days 1-5 and idarubicin (or daunorubicin) on days 1-2 of re-induction. Consolidation (if needed): If \< 60 years, cytarabine days 1,3,5 of consolidation cycles, and if ≥60 years, cytarabine days 1-5 of consolidation cycles Those with secondary or therapy-related AML can receive liposomal daunorubicin and cytarabine (Vyxeos) per standard of care as follows: Induction: Liposomal daunorubicin and cytarabine (Vyxeos) on Days 1,3, 5 of induction. Second Induction (if needed): Liposomal daunorubicin and cytarabine (Vyxeos) on days 1,3 of re-induction Consolidation (if needed): liposomal daunorubicin and cytarabine (Vyxeos) on days 1,3 of consolidation cycles |
| Investigational (Venetoclax and Azacitidine) | EXPERIMENTAL | Participants will receive azacitidine on days 1-7 and venetoclax daily for up to (3) three 28-day study cycles and evaluated for response or benefit. If benefit/response is achieved, azacitidine on days 1-7 and venetoclax on days 1-28 (or less if deemed necessary per protocol) will be given in repeating 28-day cycles until benefit/response is no longer achieved or until patient proceeds to transplantation. |
| Name | Type | Description |
|---|---|---|
| Cytarabine | DRUG | Intravenous infusion |
| Idarubicin | DRUG | Intravenous infusion |
| Daunorubicin | DRUG | Intravenous infusion |
| Liposomal daunorubicin and cytarabine | DRUG | Intravenous infusion |
| Venetoclax | DRUG | Orally by mouth |
| Azacitidine | DRUG | Intravenous infusion |
Inclusion Criteria: * Age ≥ 18 years * Participants must have pathologically confirmed, newly diagnosed acute myeloid leukemia (AML), and characterized by 20% or more blasts in the peripheral blood or bone marrow. The AML may be either: * De Novo: AML in patients with no clinical history of prio...