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Spots Global Cancer Trial Database for A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML

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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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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