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

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: A Safety Study of SGN-CD33A in AML Patients

Official Title: A Phase 1 Trial of SGN-CD33A in Patients With CD33-positive Acute Myeloid Leukemia

Study ID: NCT01902329

Interventions

HMA
SGN-CD33A

Study Description

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.

Detailed Description: This study will explore SGN-CD33A as a monotherapy and in combination with a hypomethylating agent (HMA; i.e., azacitidine or decitabine). Initial study treatment with SGN-CD33A includes a maximum of 2 cycles of treatment for monotherapy and 4 cycles for combination cohorts. Patients who achieve documented CR or CRi (Monotherapy) or clinical benefit (Combination) during the first part of the study are eligible to continue treatment. Additional monotherapy cohorts may include patients with relapsed acute promyelocytic leukemia, relapsed patients with nucleophosmin-1 gene mutation (absence of fms-like tyrosine kinase 3 mutation) (NPM1-mutated, FLT-3 wild type), alternate dosing schedules (fractionated dosing on Days 1 and 4), treatment naive patients with AML who declined intensive therapy, and patients who have relapsed after post-allogeneic stem cell transplant. Patients in the combination cohort will be treated with azacitidine or decitabine per institutional practice prior to SGN-CD33A dosing. Expansion cohorts may be added for further evaluation of safety, pharmacokinetics, pharmacodynamics, and antitumor activity.

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

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

Winship Cancer Institute / Emory University School of Medicine, Atlanta, Georgia, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Dana Farber Cancer Institute, Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Hackensack University Medical Center, Hackensack, New Jersey, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Cleveland Clinic, The, Cleveland, Ohio, 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

University of Utah, Salt Lake City, Utah, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Contact Details

Name: Phoenix Ho, MD

Affiliation: Seagen Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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