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Brief Title: A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation
Official Title: A Phase 3 Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of AB-205 Plus Standard of Care Versus Placebo Plus Standard of Care in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT) (E-CELERATE)
Study ID: NCT05181540
Brief Summary: High-dose chemotherapy followed by blood stem cell transplantation is administered to lymphoma patients with an intention to cure. However, high-dose chemotherapy simultaneously causes damage to healthy tissues that frequently result in severe complications that lead to hospitalization and can be life threatening. These severe complications involve the blood, immune, gastro-intestinal systems, and other vital organs. The purpose of this study is to determine if experimental therapy AB-205 (study drug) can prevent or reduce the occurrence and duration of the severe chemotherapy related complications when compared to placebo in patients with lymphoma undergoing treatment with high-dose chemotherapy and blood stem cell transplantation. All patients, whether treated with AB-205 or placebo, will receive standard preventive and supportive care therapies.
Detailed Description:
Minimum Age: 40 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
University of California, Los Angeles, Los Angeles, California, United States
UC Davis Comprehensive Cancer Center, Sacramento, California, United States
UC San Diego Moores Cancer Center, San Diego, California, United States
Sarah Cannon Research Institute, Colorado, Denver, Colorado, United States
Medstar Georgetown University Hospital, Washington, District of Columbia, United States
University of Miami - Sylvester Comprehensive Cancer Center, Miami, Florida, United States
University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Emory University - Winship Cancer Institute, Atlanta, Georgia, United States
University of Illinois Cancer Center, Chicago, Illinois, United States
Indiana University Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States
University Of Maryland School Of Medicine, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
University of Minnesota Medical Center, Fairview, Minneapolis, Minnesota, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Weill Cornell Medical College/New York Presbyterian Hospital, New York, New York, United States
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Name: Paul Finnegan, MD
Affiliation: Angiocrine Bioscience, Inc.
Role: STUDY_DIRECTOR