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.
NCT ID: NCT04224493
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
612 participants
INTERVENTIONAL
2020-06-11
2029-03-01
Brief Summary
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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.
Detailed Description
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In Stage 2, participants will be grouped based on whether they have a specific genetic mutation called EZH2. All participants will receive treatment in 28-day cycles. After 12 cycles, they will continue with maintenance treatment using either the study drug or a placebo, depending on their original group.
The study will include participants with and without the EZH2 mutation. Enrollment may be completed separately for each group. In China, some participants will also have extra blood tests to better understand how the drug behaves in the body.
Stage 3 will focus on long-term follow-up to monitor how well the treatment works, how safe it is, and how long participants live. All participants will be followed for up to 5 years after the last person joins the study
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
Stage 1:
Open-Label (Phase 1b: Safety run-in): All participants will receive Tazemetostat in combination with Lenalidomide and Rituximab
Stage 2:
Double-blinded (Phase 3):
* Study drug arm: Tazemetostat in combination with Lenalidomide and Rituximab
* Placebo arm: Placebo in combination with Lenalidomide and Rituximab
Stage 3:
Long-term Follow-up of participants in Stage 2 after treatment for response, when applicable, and overall survival for up to 5 years after the enrollment of the last patient in the study.
TREATMENT
QUADRUPLE
Study Groups
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Tazemetostat + R2 arm
Stage 1 (Phase 1b): This phase is now completed.
* Tazemetostat was escalated from a starting dose of 400 mg PO twice daily to 600 mg PO twice daily to 800 mg PO twice daily in 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 or 10 mg (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), administred PO QD on days 1 to 21 for 12 cycles.
Stage 2:
* Tazemetostat 800 mg 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 or 10 mg (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), PO QD on days 1 to 21 for 12 cycles.
Maintenance Therapy (Stages 1 and 2):
Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy.
Tazemetostat
Stage 1 (Phase 1b):
Tazemetostat was escalated from a starting dose of 400 mg orally twice daily to 600 mg orally twice daily to 800 mg PO twice daily in 28-day cycles as tolerated in a standard 3 + 3 design. Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy.
Tazemetostat
Stage 2:
Tazemetostat 800 mg administered orally twice daily in continuous 28-day cycles for 12 cycles. Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy.
Lenalidomide
Lenalidomide 20 mg capsules or 10 mg capsules (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles.
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 + R2 Arm
Stage 2:
* 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 or 10 mg (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles.
Maintenance Therapy (Stage 2):
Placebo will be administered as monotherapy twice daily dose for up to 2 years after the initial 12 months of combination therapy. During maintenance, placebo will be continued until disease progression or unacceptable toxicity, or participant withdraws consent.
Placebo oral tablet
Stage 2:
Placebo administered orally twice daily in continuous 28-day cycles. Placebo will be administered as monotherapy twice daily dose for up to 2 years after the initial 12 months of combination therapy.
Lenalidomide
Lenalidomide 20 mg capsules or 10 mg capsules (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles.
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.
Interventions
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Tazemetostat
Stage 1 (Phase 1b):
Tazemetostat was escalated from a starting dose of 400 mg orally twice daily to 600 mg orally twice daily to 800 mg PO twice daily in 28-day cycles as tolerated in a standard 3 + 3 design. Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy.
Tazemetostat
Stage 2:
Tazemetostat 800 mg administered orally twice daily in continuous 28-day cycles for 12 cycles. Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy.
Placebo oral tablet
Stage 2:
Placebo administered orally twice daily in continuous 28-day cycles. Placebo will be administered as monotherapy twice daily dose for up to 2 years after the initial 12 months of combination therapy.
Lenalidomide
Lenalidomide 20 mg capsules or 10 mg capsules (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Males or females are ≥18 years of age, or per country adult legal age regulations, 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
Exclusion Criteria
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. 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
a. If EZH2 mutation status is known from site-specific testing, subjects can be enrolled. Tumor tissue will be required for confirmatory testing of EZH2 status at study-specific laboratories. If the archival tumor sample was collected more than 24 months prior to the anticipated 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:
a. Absolute neutrophil count (ANC) ≥1000/mm3 (≥1.0 × 10\^9/L) if no lymphoma infiltration of bone marrow OR ANC ≥750/mm3 (≥75 × 10\^9/L) with bone marrow infiltration
* Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days.
b. Platelets ≥75,000/mm3 (≥75 × 10\^9/L)
* Evaluated at least 7 days after last platelet transfusion.
c. 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 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:
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 applicable pregnancy prevention program (e.g. REVLIMID REMS in the US, Pregnancy Prevention Programme \[PPP\] in Europe) 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.
a. Female subjects of childbearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in theapplicable pregnancy prevention program. 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, at day 14 (for FCBP with irregular menstrual cycles) and day 28 following the last dose of lenalidomide and at overall treatment discontinuation (at the End-of-Treatment/30-day safety Follow-up visit). Female subjects exempt from this requirement are subjects who have been naturally postmenopausal for at least 24 consecutive months OR are surgically sterilized (ie, total hysterectomy or bilateral oophorectomy) with surgery at least 1 month before the first dose of study treatment.
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.
All Subjects
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.
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.
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. Note: Participants who have experienced deep vein thrombosis/pulmonary embolism more than 3 months before enrollment are eligible but are 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. 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.
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.
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.
NOTE: Subjects with a history of hepatitis C infection (HCV antibody reactive) who have normal ALT and undetectable HCV RNA are eligible.
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.
18 Years
ALL
No
Sponsors
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Epizyme, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Southern Cancer Center
Mobile, Alabama, United States
Arizona Oncology Associates - Tuscon-Rusadill Road
Tucson, Arizona, United States
TOI - Clinical Research
Cerritos, California, United States
UCSF Fresno
Clovis, California, United States
UC San Diego Health Sciences
La Jolla, California, United States
UCLA Clinical Research Unit Hematology/Oncology
Santa Monica, California, United States
Rocky Mountain Cancer Centers (RMCC) - Boulder
Boulder, Colorado, United States
St. Mary's Hospital and Regional Medical Center - St. Mary's
Grand Junction, Colorado, United States
SCL Health Lutheran Medical Center
Greeley, Colorado, United States
Cancer Specialists of North Florida
Fleming Island, Florida, United States
Florida Cancer Specialists & Research Institute (FCS) - Fort Myers Cancer Center
Fort Myers, Florida, United States
Mayo Clinic - Cancer Clinical Research Office
Jacksonville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Miami Cancer Institute
Miami, Florida, United States
Florida Cancer Affiliates/Ocala Oncology - Clinic
Ocala, Florida, United States
BRCR Medical Center, INC
Plantation, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Florida Cancer Specialists - Panhandle
Tallahassee, Florida, United States
H Lee Moffitt Cancer Center and Research Institute I
Tampa, Florida, United States
Florida Cancer Specialists & Research Institute (FCS) - Atlantis
West Palm Beach, Florida, United States
Kaiser Permanente Hawaii Moanalua Medical Center
Honolulu, Hawaii, United States
University of Chicago
Chicago, Illinois, United States
Illinois Cancer Specialists
Niles, Illinois, United States
June E. Nylen Cancer Center
Sioux City, Iowa, United States
The University of Kansas Cancer Center
Overland Park, Kansas, United States
University of Maryland
Baltimore, Maryland, United States
The office of Frederick P. Smith, MD, P.C.
Chevy Chase, Maryland, United States
Mass General Cancer Center at Newton-Wellesley
Newton, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
St. Joseph Mercy Hospital
Ypsilanti, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Saint Louis University Cancer Center
St Louis, Missouri, United States
University Of Nebraska Medical Center
Omaha, Nebraska, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
Astera Cancer Center
East Brunswick, New Jersey, United States
Regional Cancer Care Associates-Freehold
Freehold, New Jersey, United States
Hackensack University Medical John Theurer Cancer Center
Hackensack, New Jersey, United States
Regional Cancer Care Associates LLC - Howell
Howell Township, New Jersey, United States
Regional Cancer Care Associates LLC - Little Silver
Little Silver, New Jersey, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
Northwell Health/Monter Cancer Center
Lake Success, New York, United States
Weill Cornell Medicine-New York Presbyterian Hospital
New York, New York, United States
Columbia U - Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Hematology Oncology Associates of Rockland, P.C.
Nyack, New York, United States
Messino Cancer Center
Asheville, North Carolina, United States
Levine Cancer Institute - Concord
Concord, North Carolina, United States
FirstHealth of the Carolinas
Pinehurst, North Carolina, United States
Regional Medical Oncology Center
Wilson, North Carolina, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Oncology Hematology Care (OHC), Inc. - Kenwood Office
Cincinnati, Ohio, United States
Willamette Valley Cancer Institute and Research Center - Oncology
Eugene, Oregon, United States
University of Pittsburgh Medical Center - Oncology
Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital Hematology & Cellular Therapy
Pittsburgh, Pennsylvania, United States
Tennessee Oncology, PLLC
Chattanooga, Tennessee, United States
University of Tennessee Medical Center - Cancer Institute
Knoxville, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology - Amarillo
Amarillo, Texas, United States
Texas Oncology-Austin Midtown
Austin, Texas, United States
Texas Oncology - Medical City Dallas Pediatric Hematology
Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Millennium Physicians - Oncology
Houston, Texas, United States
Texas Oncology
Plano, Texas, United States
Mays Cancer Center
San Antonio, Texas, United States
UT Health East Texas HOPE Cancer Center - Tyler
Tyler, Texas, United States
USO Texas Oncology - Tyler
Tyler, Texas, United States
Texas Oncology- Weslaco
Weslaco, Texas, United States
Utah Cancer Specialists/ IHO Corp
Salt Lake City, Utah, United States
Huntsman Cancer Institute; The University of Utah
Salt Lake City, Utah, United States
Peninsula Cancer Institute
Chesapeake, Virginia, United States
Virginia Cancer Specialists
Gainesville, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia Inc.
Roanoke, Virginia, United States
MC Rockwood Cancer Bl Specialty Ctr - North
Spokane, Washington, United States
Yakima Valley Memorial Hospital - North Star Lodge Cancer Center
Yakima, Washington, United States
Wheeling Hospital
Wheeling, West Virginia, United States
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Barwon Health, University Hospital Geelong
Geelong, Victoria, Australia
Hollywood Private Hospital
Nedlands, Western Australia, Australia
GenesisCare - St Andrew's
Adelaide, , Australia
Peninsula Health - Frankston
Frankston, , Australia
Royal Hobart Hospital
Hobart, , Australia
Gold Coast University Hosptial
Southport, , Australia
CHU Dinant Godinne UCL Namur
Yvoir, Namur, Belgium
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven - Campus Gasthuisberg
Leuven, Vlaams Brabant, Belgium
Hospital Haroldo Juacaba - Instituto do Cancer do Ceara
Ceará, , Brazil
Hospital Santa Cruz
Curitiba, , Brazil
HC-UFG - Hospital das CLINICAS da Universidade Federal de Go
Goiânia, , Brazil
Association Hospital de Caridade de Iju
Ijuí, , Brazil
Liga Norte Riograndense Contra o Cancer
Natal, , Brazil
Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica
Porto Alegre, , Brazil
Instituto D'Or de Pesquisa e Ensino- Recife
Recife, , Brazil
Instituto de Psiquiatria - UFRJ
Rio de Janeiro, , Brazil
Instituto Nacional de Câncer - INCA
Rio de Janeiro, , Brazil
Hospital Alemao Oswaldo Cruz (HAOC)
São Paulo, , Brazil
Instituto D'or de Pesquisa e Ensino
São Paulo, , Brazil
Instituto de Oncologia e Hematologia - HEMOMED
São Paulo, , Brazil
Irmandade Santa Casa de Misericordia de Sao Paulo
São Paulo, , Brazil
University Health Network Princess Margaret Hospital
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Sir Mortimer B Davis/Jewish General Hospital
Montreal, Quebec, Canada
Nova Scotia Health Centre for Clinical Research
Nova Scotia, , Canada
Sunnybrook Health Sciences Centre Odette Cancer Centre
Ottawa, , Canada
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang, Hangzhou, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Bethune Hospital of Jilin University
Changchun, Jinlin, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Peking University Third Hospital
Beijing, , China
Tongji Hospital of Tongji Medical College of HUST
Hangzhou, , China
Jiangxi Cancer Hospital
Nanchang, , China
Shandong Cancer Hospital
Shandong, , China
Tongji Hospital of Tongji University
Shanghai, , China
Sichuan Provincial People's Hospital
Sichuan, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
Centre Hospitalier Universitaire de Bordeaux-Hopital du Haut Leveque
Pessac, Aquitaine, France
CHRU Brest Hôp Morvan
Brest, Brittany Region, France
Institut Bergonie
Bordeaux, Gironde, France
Centre Hosp Mulh Hop Emile Muller
Mulhouse, Haut-Rhin, France
Centre Henri Becquerel
Rouen, Haute-Normandie, France
CHU de Limoges Dupuytren
Limoges, Haute-Vienne, France
CHU de Grenoble - Hopital Albe
La Tronche, Isere, France
CHU de Nantes - Hematologie
Nantes, Loire-Atlantique, France
CHRU de Lille Hop Claude Huriez
Lille, Nord, France
Centre Hospitalier Le Mans
Le Mans, Sarthe, France
Centre Hospitalier Universitaire D'Angers - Hématologie Clinique
Angers, , France
CHRU de Besançon- Hopital Jean Minjoz
Besançon, , France
CHU Caen
Caen, , France
CHU de Clermont-Ferrand, site Estaing
Clermont-Ferrand, , France
Centre Hospitalier Docteur Schaffner
Lens, , France
L'Hôpital Privé Confluent
Nantes, , France
L'hôpital Privé du Concluent
Nantes, , France
Hopital Saint Louis
Paris, , France
Centre Hospitalier - Hôpital de jour d'Hématologie
Périgueux, , France
Centre Hospitalier Universitaire de Poitiers
Poitiers, , France
CHU de Nancy Brabois
Vandœuvre-lès-Nancy, , France
Centre Hospitalier Bretagne Atlantique
Vannes, , France
Institut Gustave Roussy
Villejuif, , France
Hopital Henri Mondor - Hemopathies Lymphoides
Créteil, Île-de-France Region, France
Diakoneo Diak Schwaebisch Hall gGmbH
Schwäbisch Hall, Baden-Wurttemberg, Germany
Klinikum Der Universität München AöR
München, Bavaria, Germany
Klinikum rechts der Isar der Technischen Universitat Muenche
München, Bavaria, Germany
Universitätsmedizin Mainz
Mainz, Hesse, Germany
Universitaetsklinikum Bonn AöR
Bonn, North Rhine-Westphalia, Germany
Kliniken Maria Hilf GmbH
Mönchengladbach, North Rhine-Westphalia, Germany
Städt. Krankenhaus Kiel
Kiel, Schleswig-Holstein, Germany
Vivantes Klinikum am Urban Hämatologie und Onkologie
Berlin, , Germany
University Medical Center Schleswig Holstein
Kiel, , Germany
Debreceni Egyetem Klinikai Központ
Debrecen, Hajdú-Bihar, Hungary
Semmelweis Egyetem Általános Orvostudományi Kar
Budapest, , Hungary
Országos Onkológiai Intézet
Budapest, , Hungary
Del-pesti Centrumkorhaz Orszagos Hematologiai és Infektologiai Intezet
Budapest, , Hungary
AOU Federico II
Napoli, Campania, Italy
Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori IRCCS
Meldola, Forli-Cesena, Italy
ASST Spedali Civili di Brescia
Brescia, , Italy
PO Garibaldi-Nesima, ARNAS Garibaldi
Catania, , Italy
AOU Careggi
Florence, , Italy
Ospedale Vito Fazzi, ASL Lecce
Lecce, , Italy
IEO - Istituto Europeo di Oncologia, IRCCS
Milan, , Italy
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda
Milan, , Italy
Ospedale Niguarda, ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Ospedale San Gerardo, ASST di Monza
Monza, , Italy
Ospedale Civile S.Spirito, PO di Pescara, AUSL Pescara
Pescara, , Italy
Ospedale Infermi di Rimini, AUSL Rimini, Distretto di Rimini, Presidio di Rimini, Santarcangelo di Romagna e Novafeltria
Rimini, , Italy
Catholic University Of Sacred Heart
Roma, , Italy
PU Campus Bio-Medico di Roma
Roma, , Italy
Regina Elena, Istituto Nazionale dei Tumori , IFO, IRCCS
Roma, , Italy
Azienda Ospedaliera Santa Maria di Terni
Terni, , Italy
Azienda Ospedaliera Ordine Mauriziano di Torino, Ospedale Umberto I di Torino
Torino, , Italy
Ospedale S.Giacomo Apostolo, PO Castelfranco Veneto, AULSS 2 Marca Trevigiana
Treviso, , Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), Ospedale Maggiore
Trieste, , Italy
Centrum Medyczne Pratia Poznan
Skórzewo, Greater Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, Masovian Voivodeship, Poland
Pratia Onkologia Katowice
Katowice, , Poland
Pratia MCM Krakow
Krakow, , Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
Słupsk, , Poland
MICS Centrum Medyczne Torun
Torun, , Poland
MTZ Clinical Research powered by Pratia
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu
Wroclaw, , Poland
National Cancer Center Singapore
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea
Samsung Medical Center
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Pusan National University Hospital
Busan, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Ajou University Hospital
Suwon, , South Korea
Hospital Universitari Vall d'Hebrón
Barcelona, Cataluny, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
Hospital Del Mar
Barcelona, , Spain
Hospital Virgen de la Arrixaca
El Palmar, , Spain
Hospital Univ. Infanta Leonor
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Clínica Universidad de Navarra
Madrid, , Spain
C.H. de Navarra
Pamplona, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Nuestra Señora de Valme
Seville, , Spain
Hospital Universitario Virgen De La Macarena
Seville, , Spain
Buddihist Tzu Chi Medical Foundation- Hualien Tzu Chi Hospital
Hualien City, , Taiwan
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Ankara University Medical Faculty - Hematology
Ankara, , Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research
Ankara, , Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, , Turkey (Türkiye)
Medipol Bagcilar Mega Hospital
Istanbul, , Turkey (Türkiye)
Ondokuz Mayis University Medical Faculty - Hematology
Samsun, , Turkey (Türkiye)
Western General Hospital - Haematology
Edinburgh, Edinburgh, City of, United Kingdom
Imperial College Healthcare NHS Trust - Hammersmith Hospital
London, London City, United Kingdom
St Bartholomew's Hospital Barts Health NHS Trust
London, London, City of, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust - Clatterbridge Cancer Centre
Bebington, , United Kingdom
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Cornwell, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Northwick Park Hospital Middlesex, United Kindgom, HA1 3UJ
Middlesex, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Michael Meshad, MD
Role: primary
Sudhir Manda, MD
Role: primary
Haifaa Abdulhaq, MD
Role: primary
Benjamin Heyman
Role: primary
Sven De Vos, MD
Role: primary
David Andorsky, MD
Role: primary
Kyle Work, MD
Role: primary
Mehdi M Moezi, MD
Role: primary
Tan Han, MD
Role: primary
Ketan Doshi, MD
Role: primary
Jason Tache, MD
Role: primary
Sunil Gandhi, MD
Role: primary
Sameh Gaballa, MD
Role: primary
Shachar Peles, MD
Role: primary
Sonali Smith, MD
Role: primary
Leonard Klein, MD
Role: primary
Sano Dahlia, MD
Role: primary
Christopher Reynolds, MD
Role: primary
Jose C Villasboas Bisneto, MD
Role: primary
Julie Vose, MD
Role: primary
Bruno Fang, MD
Role: primary
Bruno Fang, MD
Role: primary
Nandini Ignatius, MD
Role: primary
Ian Horkheimer, MD
Role: primary
Leslie Andritsos, MD
Role: primary
John P Leonard, MD
Role: primary
Jennifer Amengual, MD
Role: primary
Sung Ho Lee, MD
Role: primary
Christopher Chay, MD
Role: primary
Charles Kuzma, MD
Role: primary
Nashat Gabrail, MD
Role: primary
Miguel Islas-Ohlmayer, MD
Role: primary
Jeffrey Sharman, MD
Role: primary
Viralkumar Bhanderi, MD
Role: primary
Praveen Tumula, MD
Role: primary
Jason M Melear, MD
Role: primary
Jay Courtright, MD
Role: primary
Moshe Y Levy, MD
Role: primary
Charles Yen, MD
Role: primary
Charles Connor, MD
Role: primary
Adolfo Diaz Duque, MD
Role: primary
Arielle S Lee, MD
Role: primary
Habte A Yimer, MD
Role: primary
Daniel Farray-Berges, MD
Role: primary
Stephan Kendall, MD
Role: primary
Harsh Shah, MD
Role: primary
Mitul Gandhi, MD
Role: primary
Amanda Gillespie-Twardy, MD
Role: primary
Uwe Hahn, MD
Role: primary
Lee Hui-Peng, MD
Role: primary
Stephen Opat, MD
Role: primary
Philip Campbell, MD
Role: primary
Chan Yoon Cheah, MD
Role: primary
Fritz Offner, MD
Role: primary
Ann Janssens, MD
Role: primary
Michael Crump, MD
Role: primary
Stephane Doucet, MD
Role: primary
Nathalie Johnson, MD
Role: primary
Jianzhen Shen, MD
Role: primary
Bing Xu, MD
Role: primary
Jishi Wang, MD
Role: primary
Wenbin Qian, MD
Role: primary
Lihong Liu
Role: primary
Zunmin Zhu, MD
Role: primary
Yufu Li, MD
Role: primary
Hui Zhou, MD
Role: primary
Ou Bai, MD
Role: primary
Hongwei Xue, MD
Role: primary
Weili Zhao, MD
Role: primary
Qinghau Zhang, MD
Role: primary
Hongmei Jing, MD
Role: primary
Zhengzi Qian, MD
Role: primary
Krimo Bouabdallah, MD
Role: primary
Adrian Tempescul, MD
Role: primary
Anna Schmitt, MD
Role: primary
Bernard Drenou, MD
Role: primary
Julie Abraham, MD
Role: primary
Sylvain Carras, MD
Role: primary
Franck Morschhauser, MD
Role: primary
Kamel Laribi, MD
Role: primary
Adrien Chauchet, MD
Role: primary
Steven Le Gouill, MD
Role: primary
Catherine Thieblemont, MD
Role: primary
Pierre Feugier, MD
Role: primary
Pascal Godmer, MD
Role: primary
Corinne Haioun, MD
Role: primary
Thomas Geer, MD
Role: primary
Dreyling Martin, MD
Role: primary
Georg Hess, MD
Role: primary
Franz-Georg Bauernfeind, MD
Role: primary
Ullrich Graeven, MD
Role: primary
Repp Roland, MD
Role: primary
Arpad Illes, MD
Role: primary
Zsolt Nagy, MD
Role: primary
Tamas Schneider, MD
Role: primary
Fabrizio Pane, MD
Role: primary
Gerardo Musuraca, MD
Role: primary
Alessandra Tucci, MD
Role: primary
Ugo Consoli, MD
Role: primary
Benedetta Puccini, MD
Role: primary
Stefan Hohaus, MD
Role: primary
Anna Marina Liberati, MD
Role: primary
Maciej Kazmierczak, MD
Role: primary
Jan Walewski, MD
Role: primary
Wojciech Jurczak, MD
Role: primary
Dominik Chraniuk, MD
Role: primary
Tomasz Wrobel, MD
Role: primary
Seok-Goo Cho, MD
Role: primary
Jin Seok Kim, MD
Role: primary
Won Seog Kim, MD
Role: primary
Junshik 준식 Hong 홍, MD
Role: primary
Sabela Bobillo, MD
Role: primary
Maria Espinosa Casanova, MD
Role: primary
Antonio Salar Silvestre, MD
Role: primary
José Hernández Rivas, MD
Role: primary
Miguel Canales Albendea, MD
Role: primary
Carmen Norma Gutierrez, MD
Role: primary
Eduardo Ríos Herránz, MD
Role: primary
Ming-Chung 銘崇 Wang 王, MD
Role: primary
Chieh-Lin Teng, MD
Role: primary
Ya-Ting Hsu, MD
Role: primary
Shang-Ju 尚儒 Wu 吳, MD
Role: primary
Angus Broom, MD
Role: primary
Aristeidis Chaidos, MD
Role: primary
John Gribben, MD
Role: primary
Pamela McKay, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Cao J, Chen G, Qiu L, Zhang L, Jiang M, Cheng Y, Zhang Q, Liu L, Li P, Shuang Y, Wang H, Xue H, Wu H, Zheng M, Zhou K, Li Z, Jing H, Yang W, Zhu Z, Li W, Wangwu J, Huang H, Jia Q, Chen D, Fan S, Shi MM, Su W. Efficacy and safety of tazemetostat, an EZH2 inhibitor, in Chinese patients with relapsed/refractory follicular lymphoma: a multicentre, single-arm, phase 2 study. EClinicalMedicine. 2025 Aug 18;87:103399. doi: 10.1016/j.eclinm.2025.103399. eCollection 2025 Sep.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-003333-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-510690-16-00
Identifier Type: CTIS
Identifier Source: secondary_id
EZH-302
Identifier Type: -
Identifier Source: org_study_id