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Brief Title: A Safety Study of SGN-CD123A in Patients With Acute Myeloid Leukemia
Official Title: A Phase 1 Study of SGN-CD123A in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Study ID: NCT02848248
Brief 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.
Detailed Description: This study is designed to evaluate the safety, tolerability, and preliminary estimate of antitumor activity of SGN-CD123A. The study will be conducted in 2 parts: 1. Part A is the dose-escalation portion of the trial, designed to identify the maximum tolerated dose (MTD) of SGN-CD123A 2. Part B is the dose-expansion portion of the trial, designed to evaluate SGN-CD123A in patients with differing CD123 expression levels Dose-escalation in Part A will be conducted using a 3+3 study design. Patients with CD123-detectable AML will be enrolled in cohorts at escalating doses of study drug and will receive up to 2 induction cycles of SGN-CD123A treatment at an assigned dose level in 3-week cycles. After completion of dose-escalation, patients will be enrolled in Part B of the study. Patients enrolled in Part B will receive up to 2 induction cycles of SGN-CD123A treatment at a dose level and frequency determined by results in Part A. For both Part A and Part B, a third induction cycle may be permitted with the approval of the study medical monitor. If a patient achieves a complete remission or complete remission with incomplete hematologic recovery, optional post-remission cycles of SGN-CD123A may be administered.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
City of Hope National Medical Center, Duarte, California, United States
University of Colorado Hospital / University of Colorado, Aurora, Colorado, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Hudson Valley Hematology and Oncology Associates/New York Medical College, Hawthorne, New York, United States
MD Anderson Cancer Center / University of Texas, Houston, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Name: Phoenix Ho, MD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR