Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase 1b Dose-escalation Study of SGN-CD33A in Combination With Standard-of-care for Patients With Newly Diagnosed Acute Myeloid Leukemia
This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) by itself (monotherapy) or in combination with other standard treatments. The main purpose of this study is to find the best dose and schedule for SGN-CD33A when given in combination with standard induction treatment, in combination with standard consolidation treatment, or by itself for maintenance treatment. This will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will be assessed.
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)
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