A Phase 1b Dose-escalation Study of SGN-CD33A in Combination With Standard-of-care for Patients With Newly Diagnosed Acute Myeloid Leukemia
Sponsor study identifier
interventional
116
1 country
13
Study Start
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 30, 2017
Actual (reported)Study Completion
April 10, 2018
Actual (reported)This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) by itself (monotherapy) or in combination with other standard treatments. The main purpose of this study is to find the best dose and schedule for SGN-CD33A when given in combination with standard induction treatment, in combination with standard consolidation treatment, or by itself for maintenance treatment. This 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-leukemic activity of the study treatment will be assessed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 10, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
December 18, 2014
Actual (reported)December 29, 2014
Actual (reported)January 30, 2017
Actual (reported)April 10, 2018
Actual (reported)Incidence of adverse events
Through 1 month following last dose
Incidence of laboratory abnormalities
Through 1 month following last dose
Incidence of dose-limiting toxicity (DLT)
Through 1 month following last dose
Complete remission (CR) rate at the end of induction
Through 1 month following last dose
Leukemia-free survival
Up to approximately 3 years
Overall survival
Up to approximately 3 years
Blood concentrations of SGN-CD33A and metabolites
Up to approximately 3 years
Incidence of antitherapeutic antibodies (ATA)
Up to approximately 3 years
7+3 (Standard dose cytarabine for induction and daunorubicin) + SGN-CD33A
High dose cytarabine for consolidation + SGN-CD33A (28-day cycles)
100 mg/m2/day Days 1-7
Given intravenously Day 1 or Days 1 and 4 of each cycle
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
City of Hope National Medical Center
Duarte, California, 91010-3000, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, 60153, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, 48201, United States
Hackensack University Medical Center
Eric Feldman, MD
Seagen Inc.
116 participants (actual enrollment reported by the registry).
First Submitted
December 18, 2014
First Posted
December 29, 2014
Study Start
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
A Study to Assess AC220 Given in Combination With Induction and Consolidation Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML)
SGN-CD33A Monotherapy (42-day cycles)
7+3 (standard dose cytarabine for induction and daunorubicin) + SGN-CD33A and High dose cytarabine for consolidation + SGN-CD33A
60 mg/m2/day Days 1-3
3g/m2 on Days 1, 3, and 5 of each cycle
Contact the study team to confirm eligibility.
Hackensack, New Jersey, 07601, United States
Cleveland Clinic, The
Cleveland, Ohio, 44195, United States
James Cancer Hospital / Ohio State University
Columbus, Ohio, 43210, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 30384, United States
Charles A. Sammons Cancer Center / Baylor University Medical Center
Dallas, Texas, 75246, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4095, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024, United States
Primary Completion
January 30, 2017
Actual (reported)Study Completion
April 10, 2018
Actual (reported)Last Updated
May 9, 2018
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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