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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
130
Allogeneic genetically engineered human umbilical vein endothelial cells
Placebo
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
The absence of oral/GI severe regimen related toxicities (oral/GI SRRT).
Time frame: 21 Days
Duration of oral/GI SRRT
Time frame: 21 Days
Symptom burden per MD Anderson Symptom Inventory (MDASI)
Time frame: 21 Days
Duration of febrile neutropenia
Time frame: 21 Days
Time to neutrophil engraftment
Time frame: 21 Days
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Sarah Cannon Research Institute, Colorado
Denver, Colorado, United States
Medstar Georgetown University Hospital
Washington D.C., 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
...and 18 more locations