A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML
Completed · Phase 1
Conditions studied: Acute Myeloid Leukemia, Acute Myelogenous Leukemia
In brief
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.
Key facts
- Study ID
- NCT02326584
- Run by
- Seagen Inc.
- People needed
- 116
- Starts
- 2014-12-01
- Expected to finish
- 2018-04-10
- Last updated by the study team
- 2018-05-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All subtypes of Acute Myeloid leukemia (except for acute promyelocytic leukemia)
- Eastern Cooperative Oncology Group status of 0 or 1
- Adequate baseline renal and hepatic function
- Central venous access
- Part specific requirements: eligible to receive induction; achieved CR/CRi with standard induction and eligible to receive consolidation; in CR with documented blood count recovery for maintenance
You may not qualify if…
- Previous treatment for MDS or MPN for dose escalation cohorts
- Inadequate lung function
- Inadequate heart function
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- City of Hope National Medical Center — Duarte, California, United States
- Colorado Blood Cancer Institute — Denver, Colorado, United States
- Cardinal Bernardin Cancer Center / Loyola University Medical Center — Maywood, Illinois, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Karmanos Cancer Institute / Wayne State University — Detroit, Michigan, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- Cleveland Clinic, The — Cleveland, Ohio, United States
- James Cancer Hospital / Ohio State University — Columbus, Ohio, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, 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
- Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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