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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02326584 | A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML | PHASE1 | COMPLETED | 116 | — | — | Dec 1, 2014 | Apr 10, 2018 | May 9, 2018 | 13 | United States |
| Arm | Type | Description |
|---|---|---|
| Induction with SGN-CD33A | EXPERIMENTAL | 7+3 (Standard dose cytarabine for induction and daunorubicin) + SGN-CD33A |
| Consolidation with SGN-CD33A | EXPERIMENTAL | High dose cytarabine for consolidation + SGN-CD33A (28-day cycles) |
| SGN-CD33A Maintenance | EXPERIMENTAL | SGN-CD33A Monotherapy (42-day cycles) |
| Induction and Consolidation with SGN-CD33A | EXPERIMENTAL | 7+3 (standard dose cytarabine for induction and daunorubicin) + SGN-CD33A and High dose cytarabine for consolidation + SGN-CD33A |
| Name | Type | Description |
|---|---|---|
| Standard dose cytarabine for induction | DRUG | 100 mg/m2/day Days 1-7 |
| SGN-CD33A | DRUG | Given intravenously Day 1 or Days 1 and 4 of each cycle |
| Daunorubicin | DRUG | 60 mg/m2/day Days 1-3 |
| High dose cytarabine for consolidation | DRUG | 3g/m2 on Days 1, 3, and 5 of each cycle |
Inclusion Criteria: * All subtypes of Acute Myeloid leukemia (except for acute promyelocytic leukemia) * Eastern Cooperative Oncology Group status of 0 or 1 * Adequate baseline renal and hepatic function * Central venous access * Part specific requirements: eligible to receive induction; achieved C...