RECRUITING

A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma.

Conditions

Relapsed/Refractory Follicular Lymphoma Follicular Lymphoma Refractory Follicular Lymphoma Epizyme Tazverik Tazemetostat (EPZ-6438)Lenalidomide Revlimid Rituximab Rituxan EZH2

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The participants of this study would have relapsed/refractory follicular lymphoma. Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after a period of improvement after that follows a treatment regimen and 'refractory' when treatment no longer works. Stage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3. Stage 1 of the study is completed. Stages 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo (dummy drug) in combination with other drug treatment.

Official Title

Symphony-1: A Phase 1b/3 Double-Blind, Randomized, Active-Controlled, 3-Stage, Biomarker Adaptive Study Of Tazemetostat Or Placebo In Combination With Lenalidomide Plus Rituximab In Subjects With Relapsed/Refractory Follicular Lymphoma

Quick Facts

Study Start:2020-06-11

Study Completion:2029-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04224493

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Have voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol. 2. Males or females are ≥18 years of age at the time of providing voluntary written informed consent. 3. Life expectancy ≥3 months before enrollment. 4. Meet requirement for hepatitis and human immunodeficiency virus (HIV) infection as follows * Negative serologic or polymerase chain reaction (PCR) test results for acute or chronic hepatitis B virus (HBV) infection Note: Participants whose HBV infection status could not be determined by serologic test results have to be negative for HBV-DNA by PCR to be eligible for study participation. Participants seropositive for HBV with undetectable HBV DNA by PCR are permitted with appropriate antiviral prophylaxis. * Negative test results for hepatitis C virus (HCV) Note: Participants who are positive for HCV antibody must be negative for HCV RNA by PCR to be eligible for study participation * If HIV positive, HIV infection is controlled 5. Have histologically confirmed FL, Grades 1 to 3A. 6. Must have been previously treated with at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy: 7. Must have documented relapsed, refractory, or PD after treatment with systemic therapy (refractory defined as less than PR or disease progression \<6 months after last dose). 8. Have measurable disease as defined by the Lugano Classification (Cheson, 2014; Appendix 5). 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 10. Within 7 days prior to randomization, all clinically significant toxicity related to a prior anticancer treatment (ie, chemotherapy, immunotherapy, and/or radiotherapy must have either resolved to Grade 1 per NCI CTCAE Version 5.0 OR are clinically stable and no longer clinically significant. 11. Have provided sufficient tumor tissue block or unstained slides for EZH2 mutation testing in all subjects to allow for stratification 12. Time between prior anticancer therapy and first dose of tazemetostat as follows: 1. Cytotoxic chemotherapy - At least 21 days. 2. Noncytotoxic chemotherapy (eg, small molecule inhibitor) - At least 14 days. 3. Nitrosoureas - At least 6 weeks. 4. Monoclonal and/or bispecific antibodies or CAR T - At least 28 days. 5. Radiotherapy - At least 6 weeks from prior radioisotope therapy; at least 12 weeks from 50% pelvic or total body irradiation. 13. Adequate renal function defined as calculated creatinine clearance ≥30 mL/minute per the Cockcroft and Gault formula. 14. Adequate bone marrow function: * Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days. * Evaluated at least 7 days after last platelet transfusion. * May receive transfusion 15. Adequate liver function: 1. Total bilirubin ≤1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome. 2. Alkaline phosphatase (ALP) (in the absence of bone disease), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN if subject has liver infilration). 16. International normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) ≤1.5 × ULN (unless on warfarin, then INR ≤3.0). In subjects with thromboembolism risk, prophylactic anticoagulation, or antiplatelet therapy at investigator discretion is recommended. 17. Females of childbearing potential (FCBP) must have a negative urine or serum pregnancy tests (beta-human chorionic gonadotropin \[β-hCG\] tests with a minimum sensitivity of 25 mIU/mL or equivalent units of β-hCG) at screening within 10 to 14 days prior to first dose of study drug. The subject may not receive study drug until the study doctor has verified that the results of pregnancy tests are negative. All females will be considered to be of childbearing potential unless they are naturally postmenopausal (at least 24 months consecutively amenorrhoeic \[amenorrhea following cancer therapy does not rule out childbearing potential\] and without other known or suspected cause) or have been sterilized surgically (ie, total hysterectomy and/or bilateral oophorectomy, with surgery completed at least 1 month before dosing). 18. Females of childbearing potential (FCBP) enrolled must either practice complete abstinence or agree to use two reliable methods of contraception simultaneously. This includes ONE highly effective method of contraception and ONE additional effective contraceptive method. Contraception must begin at least 28 days prior to first dose of study drug, continue during study treatment (including during dose interruptions), and for 12 months after study drug discontinuation. Female subjects must also refrain from breastfeeding for 12 months following last dose of study drug. If the below contraception methods are not appropriate for the FCBP, she must be referred to a qualified contraception provider to determine the medically effective contraception method appropriate for the subject. The following are examples of highly effective and additional effective methods of contraception: * Intrauterine device (IUD) * Hormonal (ovulation inhibitory combined \[estrogen and progesterone\] birth control pills or intravaginal/transdermal system, injections, implants, levonorgestrel-releasing intrauterine system \[IUS\], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills \[e.g. desogestrel\]) NOTE: There is a potential for tazemetostat interference with hormonal contraception methods due to enzymatic induction. * Bilateral tubal ligation * Partner's vasectomy (if medically confirmed \[azoospermia\] and sole sexual partner). * Male latex or synthetic condom, * Diaphragm, * Cervical Cap 19. All study participants enrolled must be registered into the applicable pregnancy prevention program (e.g. REVLIMID REMS in the US, Pregnancy Prevention Programme \[PPP\] in Europe, RevAid in Canada) for lenalidomide to be administered and be willing and able to comply with the requirements of the applicable program as appropriate for the country in which the drug is being used. 20. Male subjects must either practice complete abstinence or agree to use a latex or synthetic condom, even with a successful vasectomy (medically confirmed azoospermia), during sexual contact with a pregnant female or FCBP from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.	1. Prior exposure to tazemetostat or other inhibitor(s) of EZH2. 2. Prior exposure to lenalidomide or drugs of the same class. 3. Grade 3b, mixed histology, or FL that has histologically transformed to diffuse large B-cell lymphoma (DLBCL) (subjects transformed from DLBCL to FL may be enrolled). 4. Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE Version 5.0 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or myeloproliferative neoplasm (MPN). 5. Has a prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute lymphoblastic leukemia (T-ALL) or B-cell acute lymphoblastic leukemia (B-ALL). 6. Subjects with uncontrolled leptomeningeal metastases or brain metastases or history of previously treated brain metastases. 7. Subjects taking medications that are known strong CYP3A inhibitors and strong or moderate CYP3A inducers (including St. John's wort). 8. Are unwilling to exclude grapefruit juice, Seville oranges, and grapefruits from the diet and/or consumed within 1 week of the first dose of study drug and for the duration of the study. 9. Major surgery within 4 weeks before the first dose of study drug. 10. Are unable to take oral medication OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition (eg, nausea, diarrhea, vomiting) that might impair the bioavailability of tazemetostat. 11. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac ventricular arrhythmia. 12. Prolongation of corrected QT interval using Fridericia's formula (QTcF) to ≥480 msec at screening or history of long QT syndrome. 13. Venous thrombosis or pulmonary embolism within the last 3 months before starting tazemetostat. 14. Have an active infection requiring systemic therapy. 15. Known hypersensitivity to any component of tazemetostat or lenalidomide; known severe hypersensitivity to any component of rituximab requiring hospitalization or resuscitation. 16. Active viral infection with or seropositive for HBV: HBV surface antigen (HBsAg) positive OR HBsAg negative, anti-HBs positive and/or anti-HBc positive with detectable HBV DNA. 17. Active viral infection with hepatitis C virus (as measured by positive HCV antibody and detectable viral RNA, HIV), or known active infection with human T-cell lymphotropic virus. 18. Any other medical or social condition that, in the Investigator's judgment, will interfere with a participant's ability to provide informed consent, to receive study drugs, or meet study demands, or that substantially increases the risk associated with the subject's participation in the study, or that may interfere with interpretation of results. 19. Female subjects who are pregnant or lactating/breastfeeding. 20. Subjects who have undergone a solid organ transplant. 21. Subjects with malignancies other than FL. a. Exception: Subjects with another malignancy who have been disease-free for 3 years, or subjects with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.

Inclusion Criteria

Exclusion Criteria

1. Have voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.
2. Males or females are ≥18 years of age at the time of providing voluntary written informed consent.
3. Life expectancy ≥3 months before enrollment.
4. Meet requirement for hepatitis and human immunodeficiency virus (HIV) infection as follows
* Negative serologic or polymerase chain reaction (PCR) test results for acute or chronic hepatitis B virus (HBV) infection Note: Participants whose HBV infection status could not be determined by serologic test results have to be negative for HBV-DNA by PCR to be eligible for study participation. Participants seropositive for HBV with undetectable HBV DNA by PCR are permitted with appropriate antiviral prophylaxis.
* Negative test results for hepatitis C virus (HCV) Note: Participants who are positive for HCV antibody must be negative for HCV RNA by PCR to be eligible for study participation
* If HIV positive, HIV infection is controlled
5. Have histologically confirmed FL, Grades 1 to 3A.
6. Must have been previously treated with at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy:
7. Must have documented relapsed, refractory, or PD after treatment with systemic therapy (refractory defined as less than PR or disease progression \<6 months after last dose).
8. Have measurable disease as defined by the Lugano Classification (Cheson, 2014; Appendix 5).
9. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
10. Within 7 days prior to randomization, all clinically significant toxicity related to a prior anticancer treatment (ie, chemotherapy, immunotherapy, and/or radiotherapy must have either resolved to Grade 1 per NCI CTCAE Version 5.0 OR are clinically stable and no longer clinically significant.
11. Have provided sufficient tumor tissue block or unstained slides for EZH2 mutation testing in all subjects to allow for stratification
12. Time between prior anticancer therapy and first dose of tazemetostat as follows:
1. Cytotoxic chemotherapy - At least 21 days.
2. Noncytotoxic chemotherapy (eg, small molecule inhibitor) - At least 14 days.
3. Nitrosoureas - At least 6 weeks.
4. Monoclonal and/or bispecific antibodies or CAR T - At least 28 days.
5. Radiotherapy - At least 6 weeks from prior radioisotope therapy; at least 12 weeks from 50% pelvic or total body irradiation.
13. Adequate renal function defined as calculated creatinine clearance ≥30 mL/minute per the Cockcroft and Gault formula.
14. Adequate bone marrow function:
* Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days.
* Evaluated at least 7 days after last platelet transfusion.
* May receive transfusion
15. Adequate liver function:
1. Total bilirubin ≤1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome.
2. Alkaline phosphatase (ALP) (in the absence of bone disease), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN if subject has liver infilration).
16. International normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) ≤1.5 × ULN (unless on warfarin, then INR ≤3.0). In subjects with thromboembolism risk, prophylactic anticoagulation, or antiplatelet therapy at investigator discretion is recommended.
17. Females of childbearing potential (FCBP) must have a negative urine or serum pregnancy tests (beta-human chorionic gonadotropin \[β-hCG\] tests with a minimum sensitivity of 25 mIU/mL or equivalent units of β-hCG) at screening within 10 to 14 days prior to first dose of study drug. The subject may not receive study drug until the study doctor has verified that the results of pregnancy tests are negative. All females will be considered to be of childbearing potential unless they are naturally postmenopausal (at least 24 months consecutively amenorrhoeic \[amenorrhea following cancer therapy does not rule out childbearing potential\] and without other known or suspected cause) or have been sterilized surgically (ie, total hysterectomy and/or bilateral oophorectomy, with surgery completed at least 1 month before dosing).
18. Females of childbearing potential (FCBP) enrolled must either practice complete abstinence or agree to use two reliable methods of contraception simultaneously. This includes ONE highly effective method of contraception and ONE additional effective contraceptive method. Contraception must begin at least 28 days prior to first dose of study drug, continue during study treatment (including during dose interruptions), and for 12 months after study drug discontinuation. Female subjects must also refrain from breastfeeding for 12 months following last dose of study drug. If the below contraception methods are not appropriate for the FCBP, she must be referred to a qualified contraception provider to determine the medically effective contraception method appropriate for the subject. The following are examples of highly effective and additional effective methods of contraception:
* Intrauterine device (IUD)
* Hormonal (ovulation inhibitory combined \[estrogen and progesterone\] birth control pills or intravaginal/transdermal system, injections, implants, levonorgestrel-releasing intrauterine system \[IUS\], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills \[e.g. desogestrel\]) NOTE: There is a potential for tazemetostat interference with hormonal contraception methods due to enzymatic induction.
* Bilateral tubal ligation
* Partner's vasectomy (if medically confirmed \[azoospermia\] and sole sexual partner).
* Male latex or synthetic condom,
* Diaphragm,
* Cervical Cap
19. All study participants enrolled must be registered into the applicable pregnancy prevention program (e.g. REVLIMID REMS in the US, Pregnancy Prevention Programme \[PPP\] in Europe, RevAid in Canada) for lenalidomide to be administered and be willing and able to comply with the requirements of the applicable program as appropriate for the country in which the drug is being used.
20. Male subjects must either practice complete abstinence or agree to use a latex or synthetic condom, even with a successful vasectomy (medically confirmed azoospermia), during sexual contact with a pregnant female or FCBP from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.

1. Prior exposure to tazemetostat or other inhibitor(s) of EZH2.
2. Prior exposure to lenalidomide or drugs of the same class.
3. Grade 3b, mixed histology, or FL that has histologically transformed to diffuse large B-cell lymphoma (DLBCL) (subjects transformed from DLBCL to FL may be enrolled).
4. Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE Version 5.0 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or myeloproliferative neoplasm (MPN).
5. Has a prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute lymphoblastic leukemia (T-ALL) or B-cell acute lymphoblastic leukemia (B-ALL).
6. Subjects with uncontrolled leptomeningeal metastases or brain metastases or history of previously treated brain metastases.
7. Subjects taking medications that are known strong CYP3A inhibitors and strong or moderate CYP3A inducers (including St. John's wort).
8. Are unwilling to exclude grapefruit juice, Seville oranges, and grapefruits from the diet and/or consumed within 1 week of the first dose of study drug and for the duration of the study.
9. Major surgery within 4 weeks before the first dose of study drug.
10. Are unable to take oral medication OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition (eg, nausea, diarrhea, vomiting) that might impair the bioavailability of tazemetostat.
11. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac ventricular arrhythmia.
12. Prolongation of corrected QT interval using Fridericia's formula (QTcF) to ≥480 msec at screening or history of long QT syndrome.
13. Venous thrombosis or pulmonary embolism within the last 3 months before starting tazemetostat.
14. Have an active infection requiring systemic therapy.
15. Known hypersensitivity to any component of tazemetostat or lenalidomide; known severe hypersensitivity to any component of rituximab requiring hospitalization or resuscitation.
16. Active viral infection with or seropositive for HBV: HBV surface antigen (HBsAg) positive OR HBsAg negative, anti-HBs positive and/or anti-HBc positive with detectable HBV DNA.
17. Active viral infection with hepatitis C virus (as measured by positive HCV antibody and detectable viral RNA, HIV), or known active infection with human T-cell lymphotropic virus.
18. Any other medical or social condition that, in the Investigator's judgment, will interfere with a participant's ability to provide informed consent, to receive study drugs, or meet study demands, or that substantially increases the risk associated with the subject's participation in the study, or that may interfere with interpretation of results.
19. Female subjects who are pregnant or lactating/breastfeeding.
20. Subjects who have undergone a solid organ transplant.
21. Subjects with malignancies other than FL. a. Exception: Subjects with another malignancy who have been disease-free for 3 years, or subjects with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.

Contacts and Locations

Study Contact

Ipsen Clinical Study Enquiries

CONTACT

See e mail

clinical.trials@ipsen.com

Principal Investigator

Ipsen Medical Director

STUDY_DIRECTOR

Ipsen

Study Locations (Sites)

Southern Cancer Center

Mobile, Alabama, 36608

United States

Arizona Oncology Associates - Tuscon-Rusadill Road

Tucson, Arizona, 85704

United States

TOI - Clinical Research

Cerritos, California, 90703

United States

UCSF Fresno

Clovis, California, 93611

United States

UC San Diego Health Sciences

La Jolla, California, 92093

United States

UCLA Clinical Research Unit Hematology/Oncology

Santa Monica, California, 90404

United States

Rocky Mountain Cancer Centers (RMCC) - Boulder

Boulder, Colorado, 80303

United States

St. Mary's Hospital and Regional Medical Center - St. Mary's

Grand Junction, Colorado, 81501

United States

SCL Health Lutheran Medical Center

Greeley, Colorado, 80033

United States

Cancer Specialists of North Florida

Fleming Island, Florida, 32003

United States

Florida Cancer Specialists & Research Institute (FCS) - Fort Myers Cancer Center

Fort Myers, Florida, 33908

United States

Mayo Clinic - Cancer Clinical Research Office

Jacksonville, Florida, 32224

United States

Mayo Clinic

Jacksonville, Florida, 32224

United States

Miami Cancer Institute

Miami, Florida, 33176

United States

Florida Cancer Affiliates/Ocala Oncology - Clinic

Ocala, Florida, 34474

United States

BRCR Medical Center, INC

Plantation, Florida, 33322

United States

Florida Cancer Specialists

Saint Petersburg, Florida, 33705

United States

Florida Cancer Specialists - Panhandle

Tallahassee, Florida, 32308

United States

H Lee Moffitt Cancer Center and Research Institute I

Tampa, Florida, 33612

United States

Florida Cancer Specialists & Research Institute (FCS) - Atlantis

West Palm Beach, Florida, 33401

United States

Kaiser Permanente Hawaii Moanalua Medical Center

Honolulu, Hawaii, 96819

United States

University of Chicago

Chicago, Illinois, 60637

United States

Illinois Cancer Specialists

Niles, Illinois, 60714

United States

June E. Nylen Cancer Center

Sioux City, Iowa, 51101

United States

The University of Kansas Cancer Center

Overland Park, Kansas, 66210

United States

University of Maryland

Baltimore, Maryland, 21201

United States

The office of Frederick P. Smith, MD, P.C.

Chevy Chase, Maryland, 20815-6908

United States

Mass General Cancer Center at Newton-Wellesley

Newton, Massachusetts, 02462

United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

United States

St. Joseph Mercy Hospital

Ypsilanti, Michigan, 48197

United States

Mayo Clinic - Rochester

Rochester, Minnesota, 55901

United States

Saint Louis University Cancer Center

Saint Louis, Missouri, 63110

United States

University Of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Astera Cancer Care

East Brunswick, New Jersey, 08816

United States

Astera Cancer Center

East Brunswick, New Jersey, 08816

United States

Regional Cancer Care Associates-Freehold

Freehold, New Jersey, 07728

United States

Hackensack University Medical John Theurer Cancer Center

Hackensack, New Jersey, 07601

United States

Regional Cancer Care Associates LLC - Howell

Howell, New Jersey, 07731

United States

Regional Cancer Care Associates LLC - Little Silver

Little Silver, New Jersey, 07739

United States

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, 87131-0001

United States

New York Oncology Hematology, P.C.

Albany, New York, 12206

United States

Northwell Health/Monter Cancer Center

Lake Success, New York, 11042

United States

Weill Cornell Medicine-New York Presbyterian Hospital

New York, New York, 10021

United States

Columbia U - Herbert Irving Comprehensive Cancer Center

New York, New York, 10032

United States

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065

United States

Hematology Oncology Associates of Rockland, P.C.

Nyack, New York, 10960

United States

Messino Cancer Center

Asheville, North Carolina, 28806

United States

Levine Cancer Institute - Concord

Concord, North Carolina, 28205

United States

FirstHealth of the Carolinas

Pinehurst, North Carolina, 28374

United States

Gabrail Cancer Center Research

Canton, Ohio, 44718

United States

Oncology Hematology Care (OHC), Inc. - Kenwood Office

Cincinnati, Ohio, 45236

United States

Willamette Valley Cancer Institute and Research Center - Oncology

Eugene, Oregon, 97401

United States

University of Pittsburgh Medical Center - Oncology

Pittsburgh, Pennsylvania, 15232

United States

Western Pennsylvania Hospital Hematology & Cellular Therapy

Pittsburgh, Pennsylvania, 15524

United States

Tennessee Oncology, PLLC

Chattanooga, Tennessee, 37404

United States

University of Tennessee Medical Center - Cancer Institute

Knoxville, Tennessee, 37920

United States

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

United States

Texas Oncology - Amarillo

Amarillo, Texas, 79124

United States

Texas Oncology-Austin Midtown

Austin, Texas, 78705

United States

Texas Oncology - Medical City Dallas Pediatric Hematology

Dallas, Texas, 75230

United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Millennium Physicians - Oncology

Houston, Texas, 77090

United States

Texas Oncology

Plano, Texas, 75075

United States

Mays Cancer Center

San Antonio, Texas, 78229

United States

UT Health East Texas HOPE Cancer Center - Tyler

Tyler, Texas, 75701

United States

USO Texas Oncology - Tyler

Tyler, Texas, 75702

United States

Texas Oncology- Weslaco

Weslaco, Texas, 78596

United States

Utah Cancer Specialists/ IHO Corp

Salt Lake City, Utah, 84106

United States

Huntsman Cancer Institute; The University of Utah

Salt Lake City, Utah, 84112

United States

Peninsula Cancer Institute

Chesapeake, Virginia, 23320

United States

Virginia Cancer Specialists

Gainesville, Virginia, 22155

United States

Oncology and Hematology Associates of Southwest Virginia Inc.

Roanoke, Virginia, 24014

United States

MC Rockwood Cancer Bl Specialty Ctr - North

Spokane, Washington, 99218

United States

Yakima Valley Memorial Hospital - North Star Lodge Cancer Center

Yakima, Washington, 98902

United States

Collaborators and Investigators

Sponsor: Epizyme, Inc.

Ipsen Medical Director, STUDY_DIRECTOR, Ipsen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-06-11

Study Completion Date2029-03-01

Study Record Updates

Study Start Date2020-06-11

Study Completion Date2029-03-01

Terms related to this study

Keywords Provided by Researchers

Epizyme
Tazverik
Tazemetostat (EPZ-6438)
Lenalidomide
Revlimid
Rituximab
Rituxan
Follicular lymphoma
EZH2

Additional Relevant MeSH Terms

Relapsed/Refractory Follicular Lymphoma
Follicular Lymphoma
Refractory Follicular Lymphoma