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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02472145 | An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy | PHASE2 | COMPLETED | 326 | — | — | Aug 4, 2015 | Jan 25, 2018 | Mar 19, 2019 | 81 | United States, Australia +12 |
Complete response rate defined as percentage of participants who achieved complete response as per modified International Working Group (IWG) criteria. CR: Bone marrow blasts less than (\<)5 percent (%); absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (\>)1.0\*10\^9/liter (L) (1000/micro liter \[mcL\]); platelet count \>100\*10\^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis.
Overall Survival (OS) was defined as the time from the date of randomization to date of death from any cause. Median Overall Survival was estimated by using the Kaplan-Meier method. This endpoint is reported here for Part B only as per the planned analysis.
| Arm | Type | Description |
|---|---|---|
| Decitabine plus Talacotuzumab | EXPERIMENTAL | Part A: For Cycle 1 of Part A, participants will receive talacotuzumab on Day 1. Starting from Cycle 2 of Part A, participants may receive decitabine on Day 1, 2, 3, 4, and 5, and talacotuzumab on Day 8 and 22 of a 28-day cycle. Part B Arm 1: Participants will receive decitabine on Day 1, 2, 3, 4, and 5, and talacotuzumab on Day 8 and 22 of a 28-day cycle. |
| Decitabine | ACTIVE_COMPARATOR | Participants in Part B Arm 2 will receive decitabine on Day 1,2, 3, 4 and 5 of a 28-day cycle. |
| Name | Type | Description |
|---|---|---|
| Decitabine 20 mg/m^2 | DRUG | Decitabine 20 milligram per square meter (mg/\[m\^2\]) from Day 1, 2, 3, 4 and 5 of a 28-day cycle. |
| Talacotuzumab 9 mg/kg | DRUG | Talacotuzumab 9 milligram per kilogram mg/kg on Day 8 and 22 of a 28-day cycle. |
Inclusion Criteria: * De novo or secondary acute myeloid leukemia (AML) (post myelodysplastic syndrome \[MDS\] or myeloproliferative neoplasm \[MPN\] or after leukemogenic chemotherapy) according to WHO 2008 criteria For Part A: \- Participants With AML: treatment naive or relapsed for whom exper...