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

• Status: Completed
• Trial end date: 2018-04-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.
• Treatments: Cytarabine; Daunorubicin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Previous treatment for MDS or MPN for dose escalation cohorts

• Inadequate lung function

• Inadequate heart function