A Safety Study of SGN-CD33A in AML Patients

• Status: Completed
• Trial end date: 2017-12-08
• Target enrollment: 0
• Participant gender: All

Summary

This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) administered as a single agent and in combination with a hypomethylating agent (HMA). The main purpose of the study is to find the maximum tolerated dose (MTD, which is the highest dose that does not cause unacceptable side effects) of SGN-CD33A in patients with acute myeloid leukemia (AML). The MTD 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-leukemia activity of SGN-CD33A will be assessed.

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

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.

Criteria

Inclusion Criteria:

• Acute myeloid leukemia, positive for CD33

• Eastern Cooperative Oncology Group status of 0 or 1

• Adequate baseline renal and hepatic function

• Central venous access

• Either achieved complete remission (greater than 12 weeks in duration) with initial induction/consolidation and have experienced relapse of disease or declined treatment with high-dose induction/consolidation

• Bone marrow blasts greater than or equal to 5% for relapsed patients, or greater than or equal to 20% for untreated patients

Exclusion Criteria:

• Inadequate lung function

• Prior allogeneic stem cell transplant, except for a specific cohort

• High-dose chemotherapy within 4 weeks of study drug

• Antileukemia treatment within 14 days of study drug (other than hydroxyurea or 6-mercaptopurine)