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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01902329 | A Safety Study of SGN-CD33A in AML Patients | PHASE1 | COMPLETED | 195 | — | — | Jul 1, 2013 | Dec 8, 2017 | Jan 5, 2018 | 14 | United States |
| Arm | Type | Description |
|---|---|---|
| SGN-CD33A + HMA | EXPERIMENTAL | SGN-CD33A with hypomethylating agent |
| SGN-CD33A Monotherapy | EXPERIMENTAL | SGN-CD33A |
| Name | Type | Description |
|---|---|---|
| HMA | DRUG | azacitidine 75 mg/m2 for 7 days or decitabine 20mg/m2 for 5 days |
| SGN-CD33A | DRUG | Given intravenously on Day 1 or Days 1 and 4 every 3 weeks (SGN-CD33A Monotherapy) or given intravenously on the final HMA dosing day every 4 weeks (SGN-CD33A+HMA) |
Inclusion Criteria: * Acute myeloid leukemia, positive for CD33 * Eastern Cooperative Oncology Group status of 0 or 1 * Adequate baseline renal and hepatic function * Central venous access * Either achieved complete remission (greater than 12 weeks in duration) with initial induction/consolidation ...