NCT02326584

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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)

Conditions

• Acute Myeloid Leukemia
• Acute Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	Standard dose cytarabine for induction	100 mg/m2/day Days 1-7
DRUG	SGN-CD33A	Given intravenously Day 1 or Days 1 and 4 of each cycle
DRUG	Daunorubicin	60 mg/m2/day Days 1-3
DRUG	High dose cytarabine for consolidation	3g/m2 on Days 1, 3, and 5 of each cycle

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-01-30
• Completion: 2018-04-10
• First posted: 2014-12-29
• Last updated: 2018-05-09

Locations

13 sites across 1 country: United States