Study in Subjects With Relapsed/Refractory Follicular Lymphoma

• ClinicalTrials.gov Identifier: NCT04224493
• Recruitment Status: Recruiting
• First Posted: January 13, 2020
• Last Update Posted: March 9, 2023
• Sponsor: Epizyme, Inc.
• Information provided by (Responsible Party): Epizyme, Inc.

Study Description

Brief Summary:

This is a multicenter, double-blind, active-controlled, randomized, 3-stage, biomarker enrichment design featuring early futility stopping and sample-size re-estimation with safety run-in designed to evaluate the efficacy and safety of tazemetostat in combination with lenalidomide and rituximab (R2) in subjects with relapsed or refractory (R/R) follicular lymphoma (FL), who have completed at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy.

Condition or disease	Intervention/treatment	Phase
Relapsed/Refractory Follicular Lymphoma	Drug: Tazemetostat; Drug: Placebo oral tablet; Combination Product: Lenalidomide; Combination Product: Rituximab	Phase 3

Detailed Description:

Stage 1 is a safety run-in phase, stage 2 is an efficacy and safety phase for an assessment of the EZH2 Mutant Type population and overall FL population regardless of EZH2 mutation status, and optional stage 3 with efficacy and safety phase for subjects with EZH2 mutation. Stage 3 with Mutant Type population alone will be executed in case the efficacy of the overall population in stage 2 fails whilst the efficacy of EZH2 Mutant Type is sufficiently promising. Stage 2 will include 2 futility interim analyses based on ORR for the first futility and PFS for the second one. In addition, there is a possible sample size re-estimation based on PFS. This is to ensure early detection of the presence/absence of clinical efficacy benefit as well as ensuring adequate powering based on the trial results to demonstrate a meaningful efficacy difference.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 540 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: 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
• Actual Study Start Date: December 19, 2019
• Estimated Primary Completion Date: March 2026
• Estimated Study Completion Date: March 2029

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Tazemetostat + R2 Arm; tazemetostat 800mg administered PO twice daily in continuous 28-day cycles.; rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5.; lenalidomide 20 mg (if creatinine clearance ≥60 mL/minute) or 10 mg (if creatinine clearance <60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles.	Drug: Tazemetostat; Tazemetostat 800mg (tablets) administered orally twice daily in continuous 28-day cycles for 12 cycles.; Other Name: EPZ-6438; Combination Product: Lenalidomide; Lenalidomide 20 mg capsules (if creatinine clearance ≥60 mL/minute) or 10 mg capsules (if creatinine clearance <60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles.; Combination Product: Rituximab; Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5.
Placebo Comparator: Placebo + R2 Arm; placebo administered PO twice daily in continuous 28-day cycles.; rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5.; lenalidomide 20 mg (if creatinine clearance ≥60 mL/minute) or 10 mg (if creatinine clearance <60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles.	Drug: Placebo oral tablet; Placebo tablets administered PO twice daily in continuous 28-day cycles for 12 cycles.; Combination Product: Lenalidomide; Lenalidomide 20 mg capsules (if creatinine clearance ≥60 mL/minute) or 10 mg capsules (if creatinine clearance <60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles.; Combination Product: Rituximab; Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5.

Outcome Measures

Primary Outcome Measures :

1. Recommended Phase 3 Dose o(RP3D) of tazemetostat in combination with R2 [ Time Frame: Subjects are evaluated for DLTs during the first 28-day cycle. The RP3D for Phase 3 will be selected at the end of Phase 1b ]
   The safety and tolerability of tazemetostat in combination with R2 in subjects with R/R FL will be evaluated. RP3D of tazemetostat for further evaluation in phase 3 will be selected as assessed by the occurrence of treatment-emergent dose-limiting toxicities (DLTs) and adverse events (AEs).
2. Progression-free Survival (PFS) [ Time Frame: up to 72 months ]
   PFS is defined as the time from the date of randomization to the time of confirmed disease progression per the 2014 Lugano Classification or death, whichever occurs first, as assessed by Investigators.

Secondary Outcome Measures :

1. PFS [ Time Frame: up to 72 months ]
   PFS is defined as the time from the date of randomization to the time of confirmed disease progression per the 2014 Lugano Classification or death, whichever occurs first, as assessed by blinded independent review committee (IRC).
2. Objective Response Rate (ORR) [ Time Frame: up to 72 months ]
   ORR is defined as the proportion of subjects achieving partial response (PR) or complete response (CR) according to the 2014 Lugano Classification as assessed by Investigator and IRC.
3. Duration of response (DOR) [ Time Frame: up to 72 months ]
   DOR is defined as the time from initial CR or PR to documented progression or death, whichever occurs first, as assessed by Investigator and IRC.
4. Duration of complete response (DOCR) [ Time Frame: up to 72 months ]
   DOCR, defined as the time from initial CR to documented progression or death, whichever occurs first, as assessed by Investigator and IRC.
5. EuroQOL [ Time Frame: Measured at Screening, on Day 1 and Day 15 of Cycles 1 and 2, on Day 1 and optionally on Day 15 of each cycle from Cycle 3 and beyond, and at end of treatment visit, up to 3 years. (Each cycle is 28 days) ]
   Evaluate and compare health-related quality of life as measured by the EuroQOL 5-Dimension 5-Level (EQ-5D-5L) instrument and the Functional Assessment of Cancer Therapy -Lymphoma (FACT-Lym)
6. Overall Survival (OS) [ Time Frame: up to 100 weeks ]
   OS is defined as the time from the date of randomization until death due to any cause.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion 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 (≥20 years for Taiwan) at the time of providing voluntary written informed consent.
3. Life expectancy ≥3 months before enrollment.
4. Subjects with a history of hepatitis B or C are eligible on the condition that subjects have adequate liver function as defined by Inclusion Criterion #15 but with normal ALT and are hepatitis B surface antigen negative with undetectable HBV DNA and/or have undetectable hepatitis C virus (HCV) RNA if HCV antibody positive. See Exclusion Criteria 17 and 18.
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: a. Systemic therapy includes treatments such as: i. Rituximab monotherapy ii. Chemotherapy given with or without rituximab iii. Radioimmunoconjugates such as 90Y-ibritumomab tiuxetan and 131I-tositumomab.

   b. Systemic therapy does not include, for example: i. Local involved field radiotherapy for limited-stage disease ii. Helicobacter pylori eradication c. Prior investigational therapies will be allowed provided the subject has received at least

1 prior systemic therapy as discussed in Inclusion Criterion #6a. d. Prior autologous/allogeneic hematopoietic stem cell transplant (HSCT) will be allowed.

e. Prior chimeric antigen receptor T-cell therapy (CAR T) will be allowed. 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. For subjects who have experienced any clinically significant toxicity related to a prior anticancer treatment (ie, chemotherapy, immunotherapy, and/or radiotherapy):

a. At the time the subject provides voluntary written informed consent, all toxicities have either resolved to Grade 1 per National Cancer Institute CTCAE Version 5.0 OR are clinically stable and no longer clinically significant. 11. Have provided sufficient tumor tissue for EZH2 mutation testing in all subjects to allow for stratification and for CNG determination in a subset of WT EZH2 subjects from the Phase 3 portion of the study.

1. If EZH2 mutation status is known from site-specific testing, subjects can be enrolled, but additional tumor tissue will be required for confirmatory testing of EZH2 status at study-specific laboratories. If the archival tumor sample was collected more than 15 months prior to administration of the first dose (cycle 1 day 1), then a fresh biopsy must be provided. Fresh tumor biopsy is appropriate except for procedures deemed to result in unacceptable risk because of the anatomical location including brain, lung/mediastinum, pancreas, or endoscopic procedures extending beyond the esophagus, stomach, or bowel. Archival tumor biopsy sections mounted on slides are also acceptable. NOTE: Confirmatory testing will also be performed for Stage 1, if local EZH2 testing is conducted, unless there is insufficient tumor tissue to perform testing after discussion with the Sponsor's or Designee Medical Monitor. 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:

1. Absolute neutrophil count (ANC) ≥1000/mm3 (≥1.0 × 109/L) if no lymphoma infiltration of bone marrow OR ANC ≥750/mm3 (≥0.75 × 109/L) with bone marrow infiltration • Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days.

2. Platelets ≥75,000/mm3 (≥75 × 109/L)

   • Evaluated at least 7 days after last platelet transfusion.
3. Hemoglobin ≥9.0 g/dL • 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 metastases). 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 two 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 prior to dosing. The first pregnancy test must be performed within 10 to 14 days prior to first dose of study drug and the second pregnancy test must be performed within 24 hours prior to first dose of study drug. The subject may not receive study drug until the study doctor has verified that the results of these 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:

   • Examples of highly effective methods:

     • 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)

   • Examples of additional effective methods:

   - Male latex or synthetic condom

   • Diaphragm

   • Cervical Cap NOTE: Female subjects of childbearing potential exempt from these contraception requirements are subjects who practice complete abstinence from heterosexual sexual contact. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.

     19. All study participants enrolled must be registered into the mandatory Revlimid REMS™ program for the US or Revlimid Global PPP for ex-US and be willing and able to comply with the requirements of the Revlimid REMS™ or Revlimid Global PPP program as appropriate for the country in which the drug is being used.

a. Female subjects of childbearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in the Revlimid REMS™ program (for the US) or Revlimid Global PPP (for ex-US). During study treatment, FCBP must agree to have pregnancy testing weekly for the first 28 days of study participation and then every 28 days for FCBP with regular or no menstrual cycles OR every 14 days for FCBP with irregular menstrual cycles. FCBP must also have a pregnancy test at end of lenalidomide treatment, and at days 14 and 28 following the last dose of lenalidomide. Female subjects exempt from this requirement are subjects who have been naturally postmenopausal for at least 24 consecutive months OR have had a total hysterectomy and/or bilateral oophorectomy.

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.

NOTE: Male subjects must not donate semen or sperm from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.

Exclusion Criteria:

All Subjects

1. Prior exposure to tazemetostat or other inhibitor(s) of EZH2.
2. Prior exposure to lenalidomide.
3. Grade 3b, mixed histology, or FL that has histologically transformed to 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).
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) (See Section 12.1.1.1.3 and https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-druginteractions- table-substrates-inhibitors-and-inducers; https://druginteractions.

   medicine.iu.edu/MainTable.aspx).

8. Are unwilling to exclude Seville oranges, 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. AND grapefruit from their diet.
9. Major surgery within 4 weeks before the first dose of study drug. a. Note: Minor surgery (eg, minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 3 weeks prior to enrollment.
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 (Appendix 3).
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.

    a. whereas subjects greater than 3 months since deep vein thrombosis/pulmonary embolism are eligible but recommended to receive prophylaxis.

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. Inability to be treated with a Pneumocystis prophylaxis medication.
17. Active viral infection with or seropositive for hepatitis B virus (HBV): HBV surface antigen (HBsAg) positive OR HBsAg negative, anti-HBs positive and/or anti-HBc positive with detectable HBV DNA.

NOTE: Subjects who are HBsAg negative, anti-HBs positive and/or anti-HBc positive, but with undetectable viral DNA and normal ALT are eligible. Subjects who are seropositive due to HBV vaccination (HBsAg negative, HBV surface antibody [anti-HBs] positive, and HBV core antibody [anti-HBc] negative) are eligible.

18. Active viral infection with hepatitis C virus (as measured by positive HCV antibody and detectable viral RNA), human immunodeficiency virus (HIV), AND/OR human T-cell lymphotropic virus 1 (as measured by positive HTLV-1 antibody). NOTE: Subjects with a history of hepatitis C infection (HCV antibody reactive) who have normal ALT and undetectable HCV RNA are eligible. 19. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the subject's participation in this study OR interfere with their ability to receive study treatment or complete the study.

20. Female subjects who are pregnant or lactating/breastfeeding. 21. Subjects who have undergone a solid organ transplant. 22. Subjects with malignancies other than FL.

a. Exception: Subjects with another malignancy who have been disease-free for 5 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

Contacts

Contact: Clinical Trial; +1 (855) 500-1011; clinicaltrials@epizyme.com

Locations

United States, Alabama

Southern Cancer Center; Recruiting

Mobile, Alabama, United States, 36608

Contact: Michael Meshad, MD

United States, Arizona

Arizona Oncology Associates, PC - HOPE; Recruiting

Phoenix, Arizona, United States, 85016

Contact: Sudhir Manda, MD

United States, California

UCSF Fresno; Recruiting

Clovis, California, United States, 93611

Contact: Haifaa Abdulhaq, MD

Ronald Reagan UCLA Medical Center; Recruiting

Los Angeles, California, United States, 90095

Contact: Sven De Vos, MD

UC San Diego Health Sciences; Recruiting

San Diego, California, United States, 92161

Contact: Benjamin Heyman

Innovative Clinical Research Institute; Recruiting

Whittier, California, United States, 90602

Principal Investigator: Omkar Marathe, MD

United States, Colorado

Rocky Mountain Cancer Centers (RMCC) - Boulder; Recruiting

Denver, Colorado, United States, 80303

Contact: David Andorsky, MD

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

Grand Junction, Colorado, United States, 81501

Contact: Kyle Work, MD

SCL Health Lutheran Medical Center; Withdrawn

Greeley, Colorado, United States, 80033

United States, Florida

Florida Cancer Specialists; Recruiting

Fort Myers, Florida, United States, 33901

Contact: Syed Farhan Zafar, MD

Mayo Clinic - Cancer Clinical Research Office; Recruiting

Jacksonville, Florida, United States, 32224

Contact: Han Tun, MD

Mayo Clinic; Withdrawn

Jacksonville, Florida, United States, 32234

Cancer Specialists, LLC Department of Clinical Research; Recruiting

Jacksonville, Florida, United States, 32256

Contact: Mehdi M Moezi, MD

Baptist Hospital of Miami; Withdrawn

Miami, Florida, United States, 33176

Florida Cancer Affiliates; Recruiting

Ocala, Florida, United States, 34471

Contact: Ketan Doshi, MD

BRCR Medical Center, INC; Recruiting

Plantation, Florida, United States, 33432

Contact: Jason Tache, MD

Florida Cancer Specialists; Recruiting

Saint Petersburg, Florida, United States, 33709

Contact: Sunil Gandhi, MD

H Lee Moffitt Cancer Center and Research Institute I; Withdrawn

Tampa, Florida, United States, 33612

Florida Cancer Specialists; Recruiting

West Palm Beach, Florida, United States, 33401

Contact: Shachar Peles, MD

United States, Hawaii

Kaiser Permanente Hawaii Moanalua Medical Center; Recruiting

Honolulu, Hawaii, United States, 96819

Contact: Jennifer Carney, MD

United States, Illinois

University of Chicago; Recruiting

Chicago, Illinois, United States, 60637

Contact: Sonali Smith, MD

Illinois Cancer Specialists; Recruiting

Niles, Illinois, United States, 60714

Contact: Leonard Klein, MD

United States, Iowa

Siouxland Regional Cancer Center; Recruiting

Sioux City, Iowa, United States, 51101

Contact: Donald B Wender, MD

United States, Kansas

The University of Kansas Cancer Center; Withdrawn

Overland Park, Kansas, United States, 66210

United States, Maryland

University of Maryland; Withdrawn

Baltimore, Maryland, United States, 21201

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

Chevy Chase, Maryland, United States, 20815-6908

Contact: Frederick Smith, MD

United States, Massachusetts

Mass General Cancer Center at Newton-Wellesley; Withdrawn

Newton, Massachusetts, United States, 02462

United States, Michigan

St. Joseph Mercy Hospital- Inpatient Pharmacy; Recruiting

Ann Arbor, Michigan, United States, 48106

Contact: Christopher Reynolds, MD

University of Michigan; Recruiting

Ann Arbor, Michigan, United States, 48109

Contact: Ryan Wilcox, MD

United States, Minnesota

Mayo Clinic; Recruiting

Rochester, Minnesota, United States, 55905

Contact: Jose C Villasboas Bisneto, MD

United States, Missouri

SSM Health Saint Louis University Hospital; Recruiting

Saint Louis, Missouri, United States, 63110

Contact: Rajeh Nabeel Mhd, MD

United States, Nebraska

University Of Nebraska Medical Center; Recruiting

Omaha, Nebraska, United States, 68105

Contact: Julie Vose, MD

United States, New Jersey

Astera Cancer Care; Recruiting

East Brunswick, New Jersey, United States, 08816

Contact: Bruno Fang, MD

Astera Cancer Center; Recruiting

East Brunswick, New Jersey, United States, 08816

Contact: Bruno Fang, MD

Regional Cancer Care Associates-Freehold; Recruiting

Freehold, New Jersey, United States, 07728

Contact: Nandini Ignatius, MD

Hackensack University Medical John Theurer Cancer Center; Withdrawn

Hackensack, New Jersey, United States, 07601

Regional Cancer Care Associates LLC - Howell; Recruiting

Howell, New Jersey, United States, 07731

Contact: Kenneth Nahum, MD

Regional Cancer Care Associates LLC - Little Silver; Recruiting

Little Silver, New Jersey, United States, 07739

Contact: Ian Horkheimer, MD

United States, New Mexico

New Mexico Cancer Care Alliance; Recruiting

Albuquerque, New Mexico, United States, 87131-0001

Contact: Leslie Andritsos, MD

United States, New York

New York Oncology Hematology, P.C.; Withdrawn

Albany, New York, United States, 12206

Northwell Health/Monter Cancer Center; Recruiting

Lake Success, New York, United States, 11042

Contact: Joanna Rhodes, MD

Memorial Sloan-Kettering Cancer Center; Recruiting

New York, New York, United States, 10021

Principal Investigator: Connie Batlevi, MD

Columbia U - Herbert Irving Comprehensive Cancer Center; Recruiting

New York, New York, United States, 10032

Contact: Jennifer Amengual, MD

Weill Cornell Medical College; Recruiting

New York, New York, United States, 10065

Contact: John P Leonard, MD

Hematology Oncology Associates of Rockland, P.C.; Recruiting

Nyack, New York, United States, 10960

Contact: Sung Ho Lee, MD

United States, North Carolina

Messino Cancer Center; Recruiting

Asheville, North Carolina, United States, 28806

Contact: Christopher Chay, MD

Levine Cancer Institute/Atrium Health; Recruiting

Chapel Hill, North Carolina, United States, 28204

Principal Investigator: Steven Park, MD

FirstHealth of the Carolinas; Recruiting

Pinehurst, North Carolina, United States, 28374

Contact: Charles Kuzma, MD

United States, Ohio

Gabrail Cancer Center Research; Recruiting

Canton, Ohio, United States, 44718

Principal Investigator: Nashat Gabrail, MD

Gabrail Cancer Center Research; Recruiting

Canton, Ohio, United States, 44718

Contact: Nashat Gabrail, MD

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

Cincinnati, Ohio, United States, 45236

Contact: Miguel Islas-Ohlmayer, MD

United States, Oregon

Willamette Valley Cancer Institute and Research Center - Oncology; Recruiting

Eugene, Oregon, United States, 97401

Contact: Jeffrey Sharman, MD

United States, Pennsylvania

Univ. of Pittsburgh Med Center - Oncology; Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contact: Jing-Zhou Hou, MD

Western Pennsylvania Hospital Hematology & Cellular Therapy; Recruiting

Pittsburgh, Pennsylvania, United States, 15524

Principal Investigator: Cyrus M Khan, MD

United States, Tennessee

Sarah Cannon Research Institute; Recruiting

Chattanooga, Tennessee, United States, 37404

Contact: Bertrand Anz III, MD

University of Tennessee Medical Center - Cancer Institute; Recruiting

Knoxville, Tennessee, United States, 37920

Contact: Radhakrishnan Ramchandren, MD

Sarah Cannon Research Institute; Recruiting

Nashville, Tennessee, United States, 37203

Contact: Viralkumar Bhanderi, MD

Tennessee Oncology, PLLC; Recruiting

Nashville, Tennessee, United States, 37203

Contact: Ian Flinn, MD

United States, Texas

Texas Oncology - Amarillo; Recruiting

Amarillo, Texas, United States, 79106

Contact: Praveen Tumula, MD

Texas Oncology-Austin Midtown; Recruiting

Austin, Texas, United States, 78705

Contact: Jason M Melear, MD

Texas Oncology - Medical City Dallas Pediatric Hematology; Recruiting

Dallas, Texas, United States, 75230

Contact: Jay Courtright, MD

Texas Oncology-Baylor Charles A. Sammons Cancer Center; Recruiting

Dallas, Texas, United States, 75246

Contact: Moshe Y Levy, MD

The University of Texas MD Anderson Cancer Center; Recruiting

Houston, Texas, United States, 77030

Principal Investigator: Loretta Nastoupil, MD

Millennium Oncology; Recruiting

Houston, Texas, United States, 77090

Contact: Charles Yen, MD

Texas Oncology - Tyler/Longview; Recruiting

Longview, Texas, United States, 75601

Contact: Habte A Yimer, MD

Texas Oncology- Weslaco; Recruiting

McAllen, Texas, United States, 78596

Contact: Daniel Farray-Berges, MD

Texas Oncology; Recruiting

Plano, Texas, United States, 75093

Contact: Charles Connor, MD

Mays Cancer Center; Recruiting

San Antonio, Texas, United States, 78228

Contact: Adolfo Diaz Duque, MD

UT Health East Texas HOPE Cancer Center; Recruiting

Tyler, Texas, United States, 75701

Contact: Arielle S Lee, MD

United States, Utah

Utah Cancer Specialists/ IHO Corp; Recruiting

Salt Lake City, Utah, United States, 84106

Contact: Stephan Kendall, MD

Huntsman Cancer Institute; The University of Utah; Recruiting

Salt Lake City, Utah, United States, 84112

Contact: Harsh Shah, MD

United States, Virginia

Cancer Specialists of Tidewater - Chesapeake Office; Recruiting

Chesapeake, Virginia, United States, 23320

Contact: William MacLaughlin, MD

Fairfax Northern Virginia Hematology Oncology PC; Recruiting

Fairfax, Virginia, United States, 22031

Contact: Mitul Gandhi, MD

Oncology and Hematology Associates of Southwest Virginia; Recruiting

Low Moor, Virginia, United States, 24014

Contact: Amanda Gillespie-Twardy, MD

United States, Washington

Multicare Health System; Withdrawn

Spokane, Washington, United States, 99218

Yakima Valley Memorial Hospital - North Star Lodge Cancer Center; Recruiting

Yakima, Washington, United States, 98902

Contact: Sri Obulareddy, MD

Australia, South Australia

Royal Adelaide Hospital - Hematology; Recruiting

Adelaide, South Australia, Australia, 5000

Contact: Uwe Hahn, MD

Flinders Medical Centre; Withdrawn

Bedford Park, South Australia, Australia, 5042

Australia, Victoria

Monash Health - Haemotology Research; Recruiting

Clayton, Victoria, Australia, 3168

Contact: Stephen Opat, MD

Barwon Health, University Hospital Geelong; Recruiting

Geelong, Victoria, Australia, 3220

Contact: Philip Campbell, MD

Australia, Western Australia

Hollywood Private Hospital; Recruiting

Nedlands, Western Australia, Australia, 6009

Contact: Chan Yoon Cheah, MD

Belgium

CHU Dinant Godinne UCL Namur; Recruiting

Yvoir, Namur, Belgium, 5530

Contact: Marc Andre, MD

Universitair Ziekenhuis Gent; Recruiting

Gent, Belgium

Contact: Fritz Offner, MD

UZ Leuven - Campus Gasthuisberg; Withdrawn

Leuven, Belgium, 3000

Canada, Ontario

University Health Network Princess Margaret Hospital; Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contact: Michael Crump, MD

Canada, Quebec

Centre Hospitalier de l'Universite de Montreal (CHUM); Recruiting

Montréal, Quebec, Canada, H2X 0C2

Contact: Stephane Doucet, MD

Sir Mortimer B Davis/Jewish General Hospital; Recruiting

Montréal, Quebec, Canada, H3T 1E2

Contact: Nathalie Johnson, MD

China, Guizhou

The Affiliated Hospital of Guizhou Medical University; Recruiting

Guiyang, Guizhou, China, 550004

Contact: Jishi Wang, MD

China, Henan

Henan Provincial People's Hospital; Recruiting

Zhengzhou, Henan, China, 450008

Contact: Zunmin Zhu, MD

China

Peking University Third Hospital; Recruiting

Beijing, China, 100191

Contact: Hongmei Jing, MD

The First Bethune Hospital of Jilin University; Recruiting

Changchun, China

Contact: Ou Bai, MD

Fujian Medical University Union Hospital; Not yet recruiting

Fujian, China, 350001

Contact: Jianzhen Shen, MD

Hunan Cancer Hospital; Not yet recruiting

Hunan, China, 410013

Contact: Hui Zhou, MD

The Affiliated Hospital of Qingdao University; Not yet recruiting

Qingdao, China, 266071

Contact: Hongwei Xue, MD

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; Recruiting

Shanghai, China

Contact: Weili Zhao, MD

Shanxi Bethune Hospital; Recruiting

Taiyuan, China, 30032

Contact: Qinghau Zhang, MD

Tianjin Medical University Cancer Institute & Hospital; Recruiting

Tianjin, China

Contact: Zhengzi Qian, MD

The First Affiliated Hospital of Xiamen University; Not yet recruiting

Xiamen, China, 361003

Contact: Bing Xu, MD

The Second Affiliated Hospital Zhejiang University School of Medicine; Not yet recruiting

Zhejiang, China, 310000

Contact: Wenbin Qian, MD

Henan Cancer Hospital; Recruiting

Zhengzhou, China

Contact: Yufu Li, MD

France

CHU Haut-Leveque; Recruiting

Pessac, Aquitaine, France, 33600

Contact: Krimo Bouabdallah, MD

CHRU Brest Hôp Morvan; Recruiting

Brest, Bretagne, France, 29609

Contact: Adrian Tempescul, MD

CHU Caen; Recruiting

Caen, Cedex, France, 14000

Contact: Laurent (Ghandi) Damaj, MD

Institut Bergonie; Recruiting

Bordeaux, Gironde, France, 33000

Contact: Anna Schmitt, MD

GHR Mulhouse Sud Alsace - Hopital Emile Muller - Departement d'Hematologic; Recruiting

Mulhouse, Haut-Rhin, France, 68100

Contact: Bernard Drenou, MD

CHU de Limoges Dupuytren; Recruiting

Limoges, Haute-Vienne, France, 87042

Contact: Julie Abraham, MD

CHU de Grenoble - Hopital Albe; Recruiting

La Tronche, Isere, France, 38700

Contact: Sylvain Carras, MD

Service d'Hématologie Clinique Place Alexis Ricordeau; Recruiting

Nantes, Loire-Atlantique, France, 44093

Principal Investigator: Thomas Gastinne, MD

CHU de Nancy Hop Brabois; Recruiting

Vandoeuvre les Nancy, Meurthe-et-Moselle, France, 54500

Contact: Pierre Feugier, MD

CHRU de Lille Hop Claude Huriez; Recruiting

Lille, Nord, France, 59037

Contact: Franck Morschhauser, MD

CH Le Mans; Recruiting

Le Mans, Sarthe, France, 72037

Contact: Kamel Laribi, MD

CHU Jean Minjoz - Service d'Hematologie Clinique; Recruiting

Besancon, France, 25000

Contact: Adrien Chauchet, MD

CHU de Clermont Ferrand - Hopital Gabriel Montpied; Recruiting

Clermont-Ferrand, France, 63000

Contact: Steven Le Gouill, MD

Hopital Saint Louis; Recruiting

Paris, France, 75010

Contact: Catherine Thieblemont, MD

Centre Henri Becquerel; Recruiting

Rouen, France, 76038

Principal Investigator: Fabrice Jardin, MD

Centre Hospitalier Bretagne Atlantique; Recruiting

Vannes, France, 56017

Contact: Pascal Godmer, MD

Hopital Henri Mondor - Hemopathies Lymphoides; Recruiting

Créteil, Île-de-France, France, 94010

Contact: Corinne Haioun, MD

Germany

Diakoneo Diak Schwaebisch Hall gGmbH; Recruiting

Schwäbisch Hall, Baden-Württemberg, Germany, 74523

Contact: Thomas Geer, MD

Kliniken Maria Hilf GmbH; Recruiting

Moenchengladbach, Nordrhein-Westfalen, Germany, 41063

Contact: Ullrich Graeven, MD

Universitaetsklinikum Bonn; Withdrawn

Bonn, Germany, 53127

Stadtisches Krankenhaus Kiel; Withdrawn

Kiel, Germany, 24115

Universitaetsmedizin der Johannes Gutenberg-Universitat Mainz; Withdrawn

Mainz, Germany, 55131

Klinikum der Universitat Munchen Grosshadern; Withdrawn

München, Germany, 81377

Klinikum rechts der Isar der TU Munchen; Withdrawn

München, Germany, 81675

Hungary

Debreceni Egyetem Klinikai Központ; Recruiting

Debrecen, Hajdú-Bihar, Hungary, 4032

Contact: Arpad Illes, MD

Semmelweis Egyetem Klinikai Központ; Recruiting

Budapest, Hungary, 1088

Contact: Zsolt Nagy, MD

Del-pesti Centrumkorhaz Orszagos Hematologiai és Infektologiai Intezet; Recruiting

Budapest, Hungary, 1097

Contact: Gabor Mikala, MD

Országos Onkológiai Intézet; Recruiting

Budapest, Hungary, 1122

Contact: Tamas Schneider, MD

Italy

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", IRCCS - Oncologia; Recruiting

Meldola, Forli, Italy, 47014

Contact: Gerardo Musuraca, MD

Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore; Recruiting

Roma, Lazio, Italy, 00168

Contact: Stefan Hohaus, MD

AO Spedali Civili di Brescia, PO Spedali Civili; Recruiting

Brescia, Italy, 25123

Contact: Alessandra Tucci, MD

Presidio Ospedaliero Garibaldi-Nesima U. O. C.; Recruiting

Catania, Italy, 95122

Contact: Ugo Consoli, MD

AOU Careggi, Servizio Sanitario Toscana; Recruiting

Firenze, Italy, 50134

Contact: Benedetta Puccini, MD

Azienda Universitaria Ospedaliera Federico II di Napoli; Withdrawn

Napoli, Italy, 80122

Azienda Ospedaliera Santa Maria di Terni; Recruiting

Terni, Italy, 05100

Contact: Anna Marina Liberati, MD

Korea, Republic of

Severance Hospital, Yonsei University Health System - Haematology and Oncology; Recruiting

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of, 03722

Contact: Jin Seok Kim, MD

Samsung Medical Center - Hematology-Oncology; Recruiting

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of, 06351

Contact: Won Seog Kim, MD

The Catholic University of Korea, Seoul St. Mary's Hospital; Recruiting

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of, 06591

Contact: Seok-Goo Cho, MD

Seoul National University Hospital - Department of Internal; Recruiting

Seoul, Korea, Republic of

Contact: Junshik 준식 Hong 홍, MD

Poland

Nasz Lekarz Osrodek Badan Klinicznych; Recruiting

Torun, Kujawsko-pomorskie, Poland, 87-100

Contact: Dominik Chraniuk, MD

Pratia MCM Krakow; Recruiting

Kraków, Malopolskie, Poland, 30-510

Contact: Wojciech Jurczak, MD

Centrum Medyczne Pratia Poznan; Recruiting

Skorzewo, Poland, 60-185

Contact: Maciej Kazmierczak, MD

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.; Recruiting

Słupsk, Poland

Contact: Wojciech Homenda, MD

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy; Recruiting

Warszawa, Poland, 02-781

Contact: Jan Walewski, MD

Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu; Recruiting

Wroclaw, Poland

Contact: Tomasz Wrobel, MD

Spain

Hospital Del Mar; Recruiting

Barcelona, Spain, 08003

Contact: Antonio Salar Silvestre, MD

Hospital Universitari Vall d'Hebrón Servicio de Hematología; Recruiting

Barcelona, Spain

Contact: Sabela Bobillo, MD

Hospital Univ. Infanta Leonor; Recruiting

Madrid, Spain, 28031

Contact: José Hernández Rivas, MD

Hospital Universitario La Paz; Recruiting

Madrid, Spain, 28046

Contact: Miguel Canales Albendea, MD

H Comarcal Costa del Sol; Recruiting

Marbella, Spain, 29603

Contact: Maria Espinosa Casanova, MD

Hospital Universitario de Salamanca IBSAL CIBERONC; Recruiting

Salamanca, Spain, 37007

Contact: Carmen Norma Gutierrez, MD

Hospital Universitario Nuestra Señora de Valme; Recruiting

Sevilla, Spain, 41014

Contact: Eduardo Ríos Herránz, MD

Taiwan

Taichung Veterans General Hospital; Recruiting

Taichung City, Xitun District, Taiwan, 40705

Contact: Chieh-Lin Teng, MD

Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology; Recruiting

Kaohsiung, Taiwan

Contact: Ming-Chung 銘崇 Wang 王, MD

National Cheng Kung University Hospital; Recruiting

Tainan, Taiwan, 704

Contact: Ya-Ting Hsu, MD

National Taiwan University Hospital; Recruiting

Taipei, Taiwan

Contact: Shang-Ju 尚儒 Wu 吳, MD

United Kingdom

Western General Hospital; Recruiting

Edinburgh, Edinburgh, City Of, United Kingdom, EH4 2XU

Contact: Angus Broom, MD

St Bartholomew's Hospital Barts Health NHS Trust; Recruiting

London, London, City Of, United Kingdom, EC1A 7BE

Contact: John Gribben, MD

Beatson West of Scotland Cancer Centre; Recruiting

Glasgow, United Kingdom, G12 0YN

Contact: Pamela McKay, MD

Imperial College Healthcare NHS Trust - Hammersmith Hospital; Withdrawn

London, United Kingdom, W12 0HS

Sponsors and Collaborators

Epizyme, Inc.

More Information

• Responsible Party: Epizyme, Inc.
• ClinicalTrials.gov Identifier: NCT04224493
• Other Study ID Numbers: EZH-302
• First Posted: January 13, 2020
• Last Update Posted: March 9, 2023
• Last Verified: March 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Epizyme, Inc.:

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

Additional relevant MeSH terms:

Lymphoma; Lymphoma, Follicular; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Rituximab; Lenalidomide; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors