A Safety Study of SGN-CD33A in AML Patients
A Phase 1 Trial of SGN-CD33A in Patients With CD33-positive Acute Myeloid Leukemia
1 other identifier
interventional
195
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2013
Longer than P75 for phase_1
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 15, 2013
CompletedFirst Posted
Study publicly available on registry
July 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2017
CompletedJanuary 5, 2018
January 1, 2018
2.7 years
July 15, 2013
January 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of adverse events
Through 1 month following last dose
Incidence of laboratory abnormalities
Through 1 month following last dose
Secondary Outcomes (6)
Blood concentrations of SGN-CD33A and metabolites
Through 3 weeks after dosing
Incidence of antitherapeutic antibodies
Through 1 month following last dose
Rate of complete remission
Up to 3 months
Duration of complete remission
Up to approximately 3 years
Relapse-free survival
Up to approximately 3 years
- +1 more secondary outcomes
Study Arms (2)
SGN-CD33A + HMA
EXPERIMENTALSGN-CD33A with hypomethylating agent
SGN-CD33A Monotherapy
EXPERIMENTALSGN-CD33A
Interventions
Given intravenously on Day 1 or Days 1 and 4 every 3 weeks (SGN-CD33A Monotherapy) or given intravenously on the final HMA dosing day every 4 weeks (SGN-CD33A+HMA)
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
Study Sites (14)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
City of Hope National Medical Center
Duarte, California, 91010-3000, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Winship Cancer Institute / Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Cleveland Clinic, The
Cleveland, Ohio, 44195, 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
University of Utah
Salt Lake City, Utah, 84112, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024, United States
Related Publications (1)
Stein EM, Walter RB, Erba HP, Fathi AT, Advani AS, Lancet JE, Ravandi F, Kovacsovics T, DeAngelo DJ, Bixby D, Faderl S, Jillella AP, Ho PA, O'Meara MM, Zhao B, Biddle-Snead C, Stein AS. A phase 1 trial of vadastuximab talirine as monotherapy in patients with CD33-positive acute myeloid leukemia. Blood. 2018 Jan 25;131(4):387-396. doi: 10.1182/blood-2017-06-789800. Epub 2017 Dec 1.
PMID: 29196412DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Phoenix Ho, MD
Seagen Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2013
First Posted
July 18, 2013
Study Start
July 1, 2013
Primary Completion
March 18, 2016
Study Completion
December 8, 2017
Last Updated
January 5, 2018
Record last verified: 2018-01