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Brief Title: SYMPHONY-2, A Trial to Examine Combination of Tazemetostat With Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma
Official Title: SYMPHONY-II: A Phase II Open-Label, Multicenter Trial of Oral Tazemetostat in Combination With Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma
Study ID: NCT04762160
Brief Summary: This study evaluates the safety and efficacy of combining the EZH2 inhibitor tazemetostat with rituximab in R/R FL subjects previously treated with at least 2 standard prior systemic treatment regimens where at least 1 anti-CD20-based regimen was used.
Detailed Description: This is a phase 2, multicenter, open-label study of oral tazemetostat in combination with rituximab in subjects with relapsed or refractory (R/R) follicular lymphoma (FL). This study is designed to evaluate the safety and efficacy of tazemetostat in combination with rituximab in subjects previously treated with at least 2 standard prior systemic treatment regimens where at least 1 anti-CD20-based regimen was used, and used and features early futility stopping to maintain subject safety.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Alabama Oncology, Birmingham, Alabama, United States
Compassionate Cancer Care, Fountain Valley, California, United States
USOR/Rocky Mountain Cancer Centers, Boulder, Colorado, United States
USOR/ Illinois Cancer Specialists, Niles, Illinois, United States
XCancer/ Northwest Oncology & Hematology, Rolling Meadows, Illinois, United States
Revive/Oakland Medical Group, Farmington Hills, Michigan, United States
Revive/Hematology Oncology Associates of Rockland, Sterling Heights, Michigan, United States
USOR/ NY Oncology Hematology, Albany, New York, United States
East Carolina University, Greenville, North Carolina, United States
USOR/ Oncology & Hematology Care Clinical Trials, Cincinnati, Ohio, United States
XCancer/Dayton Physicians Network, Kettering, Ohio, United States
XCancer/Tennessee Cancer Specialists, Knoxville, Tennessee, United States
USOR/ Texas Oncology, Austin, Texas, United States
USOR/Texas Oncology, Dallas, Texas, United States
USOR/ Texas Oncology, San Antonio, Texas, United States
USOR/ Texas Oncology, Tyler, Texas, United States
USOR/Texas Oncology, Weslaco, Texas, United States
USOR/Virginia Cancer Specialists, Gainesville, Virginia, United States
USOR/Oncology & Hematology Associates of Southwest Virginia, Roanoke, Virginia, United States
Swedish Cancer Institute, Seattle, Washington, United States
Name: Ipsen Medical Director
Affiliation: Ipsen
Role: STUDY_DIRECTOR