A Safety Study of SGN-CD33A in AML Patients

Completed · Phase 1

Conditions studied: Acute Myelogenous Leukemia, Acute Myeloid Leukemia, Acute Promyelocytic Leukemia

In brief

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.

Key facts

Study ID

NCT01902329

Run by

Seagen Inc.

People needed

195

Starts

2013-07-01

Expected to finish

2017-12-08

Last updated by the study team

2018-01-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• City of Hope National Medical Center — Duarte, California, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Winship Cancer Institute / Emory University School of Medicine — Atlanta, Georgia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Cleveland Clinic, The — Cleveland, Ohio, United States
• Charles A. Sammons Cancer Center / Baylor University Medical Center — Dallas, Texas, United States
• MD Anderson Cancer Center / University of Texas — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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