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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Epizyme, Inc.
Study ID
NCT04762160
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tazemetostat — DRUG
    Study Drug
  • Rituximab — COMBINATION_PRODUCT
    Partner Drug

Study Details

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 Dates

Start date
Dec 15, 2020
Status verified
Mar 2024
Primary completion
Mar 22, 2022
Completion
Mar 22, 2022

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Planned to be assessed during Cycles 3, 6, 12, 18, and 24. ]

Locations (20)

FacilityCityStateZIPSite coordinators
Alabama OncologyBirminghamAlabama35223-
Compassionate Cancer CareFountain ValleyCalifornia92708-
USOR/Rocky Mountain Cancer CentersBoulderColorado80303-
USOR/ Illinois Cancer SpecialistsNilesIllinois60714-
XCancer/ Northwest Oncology & HematologyRolling MeadowsIllinois60008-
Revive/Oakland Medical GroupFarmington HillsMichigan48336-
Revive/Hematology Oncology Associates of RocklandSterling HeightsMichigan48314-
USOR/ NY Oncology HematologyAlbanyNew York12206-
East Carolina UniversityGreenvilleNorth Carolina27858-
USOR/ Oncology & Hematology Care Clinical TrialsCincinnatiOhio45236-
XCancer/Dayton Physicians NetworkKetteringOhio45409-
XCancer/Tennessee Cancer SpecialistsKnoxvilleTennessee37909-
USOR/ Texas OncologyAustinTexas78705-
USOR/Texas OncologyDallasTexas75230-
USOR/ Texas OncologySan AntonioTexas78240-
USOR/ Texas OncologyTylerTexas75702-
USOR/Texas OncologyWeslacoTexas78596-
USOR/Virginia Cancer SpecialistsGainesvilleVirginia20155-
USOR/Oncology & Hematology Associates of Southwest VirginiaRoanokeVirginia24014-
Swedish Cancer InstituteSeattleWashington98104-

Find similar trials in Birmingham, AL

By research site
Alabama Oncology· Birmingham, ALCompassionate Cancer Care· Fountain Valley, CAUSOR/Rocky Mountain Cancer Centers· Boulder, COUSOR/ Illinois Cancer Specialists· Niles, ILXCancer/ Northwest Oncology & Hematology· Rolling Meadows, ILRevive/Oakland Medical Group· Farmington Hills, MI

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