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7+3 (Standard dose cytarabine for induction and daunorubicin) + SGN-CD33A

High dose cytarabine for consolidation + SGN-CD33A (28-day cycles)

7+3 (standard dose cytarabine for induction and daunorubicin) + SGN-CD33A and High dose cytarabine for consolidation + SGN-CD33A

Standard dose cytarabine for induction

Given intravenously Day 1 or Days 1 and 4 of each cycle

SGN-CD33A

High dose cytarabine for consolidation

Eric Feldman, MD

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)

A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML

A Phase 1b Dose-escalation Study of SGN-CD33A in Combination With Standard-of-care for Patients With Newly Diagnosed Acute Myeloid Leukemia

Seagen Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML	NCT02326584	Acute Myeloid L... Acute Myelogeno...	Standard dose c... SGN-CD33A Daunorubicin High dose cytar...	18 Years -	Seagen Inc.
A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML	NCT02326584	Acute Myeloid L... Acute Myelogeno...	Standard dose c... SGN-CD33A Daunorubicin High dose cytar...	18 Years -	Seagen Inc.

Spots Global Cancer Trial Database for high dose cytarabine for consolidation