Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Seagen Inc.
The study will be conducted in the following distinct parts:
Part A: Induction dose escalation - 7+3 combined with SGN-CD33A (Day 1 and Day 4 dosing)
Part B: Consolidation dose escalation - consolidation combined with SGN-CD33A; up to 4 cycles of consolidation therapy will be administered after SGN-CD33A (Day 1 of each cycle).
Part C: Maintenance - SGN-CD33A Monotherapy; Up to 24 patients with and up to 24 patient without prior allogeneic stem cell transplant will be treated with SGN-CD33A. Both arms will enroll simultaneously. SGN-CD33A will be administered on Day 1 of each 6-week cycle for up to 8 cycles.
Part D: Induction plus consolidation - induction/consolidation combined with SGN-CD33A; patients who achieve a CR/CRi (with or without a second induction) will receive up to 4 cycles of consolidation therapy administered after SGN-CD33A (Day 1 of each cycle).
Part E: Induction dose escalation - 7+3 combined with SGN-CD33A (Day 1 dosing)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 CR/CRi with standard induction and eligible to receive consolidation; in CR with documented blood count recovery for maintenance
You may not be if
Previous treatment for MDS or MPN for dose escalation cohorts