A Safety Study of SGN-CD123A in Patients With Acute Myeloid Leukemia

• Status: Terminated
• Trial end date: 2018-04-06
• Target enrollment: 0
• Participant gender: All

Summary

The study will examine the safety profile of SGN-CD123A. The study will test increasing doses of SGN-CD123A given every 3 weeks to patients.

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

Details

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

Criteria

Inclusion Criteria:

• Relapsed/refractory acute myeloid leukemia following at least 2 but no more than 3 prior regimens

• Patients may be eligible after only 1 previous regimen if in a high risk category

• Adequate baseline renal and hepatic function

• Eastern Cooperative Oncology Group Status of 0 or 1

• CD123-detectable leukemia

Exclusion Criteria:

• Cerebral/meningeal disease related to underlying malignancy

• Promyelocytic leukemia

• History of clinically significant pulmonary fibrosis or documented diffusing capacity of the lung for carbon monoxide <50% predicted

• Prior hematopoietic stem cell transplant

• Antileukemia or experimental treatment within 4 weeks of study drug (other than hydroxyurea or 6-mercaptopurine)

• Cardio or cerebral vascular event within 6 months