SYMPHONY-2, A Trial to Examine Combination of Tazemetostat With Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma

Stopped early · Phase 2

Conditions studied: Follicular Lymphoma

In brief

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.

Key facts

Study ID

NCT04762160

Run by

Epizyme, Inc.

People needed

5

Starts

2020-12-15

Expected to finish

2022-03-22

Last updated by the study team

2024-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women of 18 years of age and older
• Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
• Eastern Cooperative Oncology Group (ECOG) score of 0 </=, 1 or 2
• Life expectancy (in the opinion of the investigator) of >3 months before enrollment
• Have histologically confirmed FL, Grade 1 to 3a. Subjects may have R/R disease following at least 2 standard prior systemic treatment regimens where at least 1 anti- CD20-based regimen was used
• Treatment recommended in accordance with the Groupe d'Etude des Lymphomes b Folliculaires (GELF) criteria
• Meet the following laboratory parameters:
• Absolute neutrophil count (ANC) ≥ 750 cells/μL (0.75 x 109/L), or ≥ 500 cells/μL (0.50 x 109/L) in subjects with documented bone marrow involvement
• Platelet count ≥ 50,000 cells/μL (50 x 109/L), or ≥ 30,000 cells/μL (30 x 109/L) in subjects with documented bone marrow involvement, and without transfusion dependence
• Hemoglobin ≥ 8 g/dL
• Serum alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ Incl3.0 x ULN, unless related to disease involvement
• Total bilirubin ≤ 1.5 x ULN, unless due to disease involvement, Gilbert's syndrome, or hemolytic anemia
• Estimated creatinine clearance (ie, estimated glomerular filtration rate [eGFR] using Cockcroft-Gault) ≥ 40 mL/min
• At least one bi-dimensionally measurable nodal lesion > 1.5 cm in its longest diameter by computed tomography (CT) scan or magnetic resonance imaging (MRI)
• Any clinically significant toxicity related to a prior anticancer treatment (ie, chemotherapy, immunotherapy, and/or radiotherapy), except for alopecia, either resolved to ≤ Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 or is clinically stable and no longer clinically significant
• Negative serologic or polymerase chain reaction (PCR) test results for acute or chronic hepatitis B virus (HBV) infection
• Negative test results for hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
• Females of childbearing potential (FCBP) must have a negative serum pregnancy test (beta-human chorionic gonadotropin [β-hCG] test with a minimum sensitivity of 25 mIU/mL or equivalent units of β-hCG) at screening and within 24 hours prior to the first dose of study drug.
• FCBP must either practice complete abstinence or agree to use a highly effective method of contraception beginning at least 28 days prior to the first dose of study drug, during study treatment (including during dose interruptions), for 6 months after tazemetostat discontinuation, and for 12 months after rituximab discontinuation. .
• Male subjects must have had a successful vasectomy (with medically confirmed azoospermia) OR must either practice complete abstinence or agree to use a latex or synthetic condom during sexual contact with a FCBP from the first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.

You may not qualify if…

• Prior exposure to Tazemetostat or other inhibitor(s) of EZH2
• Grade 2b, mixed histology, or transformed FL
• Treatment with any of the following anticancer therapies within the timeframe of a specific treatment prior to first dose of study drug:
• Cytotoxic chemotherapy within 21 days
• Noncytotoxic chemotherapy (e.g. small molecule inhibitor) within 14 days
• Nitrosoureas within 6 weeks
• Prior immunotherapy within 4 weeks
• Radiotherapy- within 6 weeks from prior radioisotope therapy; within 12 weeks from 50% pelvic or total body irradiation
• Any investigational treatment within 4 weeks or at least 5 half lives, whichever is shorter
• History of solid organ transplant
• Major surgery within 4 weeks of the start of study treatment
• Thrombocytopenia, neutropenia, or anemia of Grade > 3 (per CTCAE v5.0 criteria) or any prior history of myeloid malignancies, including MDS/AML or MPN
• Prior history of T-LBL/T-ALL
• Unwillingness to exclude grapefruit juice-containing products, Seville oranges, and grapefruits from the diet and/ or consumed within 1 week of the first dose of study drug
• Subjects taking medications that are known strong cytochrome P450 (CYP)3A inhibitors and strong or moderate CYP3A inducers (including St. John's wort)
• Any uncontrolled illness
• History of clinically significant cardiovascular abnormalities
• History of clinically significant gastrointestinal (GI) conditions
• Other diagnosis of cancer that is likely to require treatment in the next 2 years
• Females who are pregnant or lactating/breastfeeding
• Received a live virus vaccination within 28 days of first dose of rituximab
• Concurrent participation in a separate investigational therapeutic study
• Psychiatric illness/social situations that would interfere with study compliance

Where it is running

• 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

Full record on ClinicalTrials.gov

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