SYMPHONY-2, A Trial to Examine Combination of Tazemetostat With Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma
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|ClinicalTrials.gov Identifier: NCT04762160|
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : April 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Follicular Lymphoma||Drug: Tazemetostat Combination Product: Rituximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 3, 2021|
|Estimated Primary Completion Date :||July 2026|
|Estimated Study Completion Date :||September 2026|
Experimental: Tazmetostat in combination with rituximab
Tazemetostat 800 mg BID is administered daily starting on Cycle 1 Day 1 (C1D1). Tazemetostat will be administered from C1D1 to the end of Cycle 24, for 24 months of therapy or until disease progression, unacceptable toxicity, or withdrawal of consent. Rituximab will be administered by either subcutaneous injection or IV infusion according to the regional product prescribing information, labeling and institutional guidelines. Rituximab will be administered at a dose of 375 mg/m2 on Day 1, 8, 15, and 22 of Cycle 1, and then on Day 1 of Cycles 3 through 6, accounting for an additional 4 doses, i.e., a total of 8 doses of rituximab in 6 cycles.
Other Name: EPZ-6438
Combination Product: Rituximab
Other Name: Rituximab Hyaluronidase
- Objective Response Rate [ Time Frame: Assessed by Investigator and blinded independent review committee (IRC) at the following time points: Cycle 3, Cycle 6, Cycle 12, Cycle 18, and Cycle 24. Each cycle is 28 days. ]Assess the objective response rate (ORR; complete response + partial response [CR + PR]), according to 2014 Lugano Classification, of Tazemetostat, in combination with Rituximab in subjects with relapsed/refractory follicular lymphoma and with wild-type (WT) EZH2 mutation status.
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: Adverse events collected from time of signing informed consent to either 30 days after last dose of study drug or initiation of subsequent anticancer therapy, whichever occurs first ]Evaluate safety of the combination of Tazemetostat and Rituximab by assessing incidence of adverse events (AEs)/serious adverse events (SAEs), events leading to discontinuation of study treatment or death, and change of vital signs, lab results, and physical exam findings from baseline. Outcome measured according to National Cancer (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Progression Free Survival [ Time Frame: From first dose of study drug to earliest date of disease progression or death as assessed up to 24 months by an IRC ]Estimate the median progression-free survival (PFS), per 2014 Lugano Classification, of Tazemetostat in combination with Rituximab at 2 years in subjects with R/R follicular lymphoma and WT EZH2 mutation status, and in the pooled group regardless of mutation status.
- Duration of Response [ Time Frame: From earliest date of CR or PR to documented progression or death as assessed up to 24 months by an IRC ]Estimate the duration of response (DOR).) per 2014 Lugano Classification.
- Response Rate in a subset of subjects with mutant (MT) EZH2 [ Time Frame: Assessed at the following timepoints: Cycle 3, Cycle 6, Cycle 12, Cycle 18, and Cycle 24. Each cycle is 28 days. ]Assess the ORR, according to 2014 Lugano Classification, in the pooled group regardless of mutation status and in a subset of subjects with MT EZH2.
- Response rate in rituximab refractory subjects [ Time Frame: Assessed at the following timepoints: Cycle 3, Cycle 6, Cycle 12, Cycle 18, and Cycle 24. Each cycle is 28 days. ]Assess the ORR, according to 2014 Lugano Classification, in rituximab refractory subjects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04762160
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