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Brief Title: A Safety Study of SGN-CD33A in AML Patients
Official Title: A Phase 1 Trial of SGN-CD33A in Patients With CD33-positive Acute Myeloid Leukemia
Study ID: NCT01902329
Brief 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.
Detailed Description: This study will explore SGN-CD33A as a monotherapy and in combination with a hypomethylating agent (HMA; i.e., azacitidine or decitabine). Initial study treatment with SGN-CD33A includes a maximum of 2 cycles of treatment for monotherapy and 4 cycles for combination cohorts. Patients who achieve documented CR or CRi (Monotherapy) or clinical benefit (Combination) during the first part of the study are eligible to continue treatment. Additional monotherapy cohorts may include patients with relapsed acute promyelocytic leukemia, relapsed patients with nucleophosmin-1 gene mutation (absence of fms-like tyrosine kinase 3 mutation) (NPM1-mutated, FLT-3 wild type), alternate dosing schedules (fractionated dosing on Days 1 and 4), treatment naive patients with AML who declined intensive therapy, and patients who have relapsed after post-allogeneic stem cell transplant. Patients in the combination cohort will be treated with azacitidine or decitabine per institutional practice prior to SGN-CD33A dosing. Expansion cohorts may be added for further evaluation of safety, pharmacokinetics, pharmacodynamics, and antitumor activity.
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
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
Name: Phoenix Ho, MD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR