Spots Global Cancer Trial Database for A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML
Official Title: A Phase 1b Dose-escalation Study of SGN-CD33A in Combination With Standard-of-care for Patients With Newly Diagnosed Acute Myeloid Leukemia
Study ID: NCT02326584
Study Description
Brief Summary: 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.
Detailed Description: The study will be conducted in the following distinct parts: Part A: Induction dose escalation - 7+3 combined with SGN-CD33A (Day 1 and Day 4 dosing) Part B: Consolidation dose escalation - consolidation combined with SGN-CD33A; up to 4 cycles of consolidation therapy will be administered after SGN-CD33A (Day 1 of each cycle). Part C: Maintenance - SGN-CD33A Monotherapy; Up to 24 patients with and up to 24 patient without prior allogeneic stem cell transplant will be treated with SGN-CD33A. Both arms will enroll simultaneously. SGN-CD33A will be administered on Day 1 of each 6-week cycle for up to 8 cycles. Part D: Induction plus consolidation - induction/consolidation combined with SGN-CD33A; patients who achieve a CR/CRi (with or without a second induction) will receive up to 4 cycles of consolidation therapy administered after SGN-CD33A (Day 1 of each cycle). Part E: Induction dose escalation - 7+3 combined with SGN-CD33A (Day 1 dosing)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Eric Feldman, MD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
