Study of Tazemetostat Versus Placebo When Given in Combination With Lenalidomide and Rituximab in Participants With Relapsed/Refractory Follicular Lymphoma (SYMPHONY-1)

• ClinicalTrials.gov Identifier: NCT04224493
• Recruitment Status: Recruiting
• First Posted: January 13, 2020
• Last Update Posted: May 8, 2024
• Sponsor: Epizyme, Inc.
• Information provided by (Responsible Party): Ipsen ( Epizyme, Inc. )

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Relapsed/Refractory Follicular Lymphoma; Follicular Lymphoma; 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, was designed to evaluate the safety of the combination of tazemetostat and R2, as well as to establish the RP3D for Stage 2, which is now completed.

Stage 2 is an efficacy and safety phase for an assessment of the FL population with the enhancer of zeste homolog 2 (EZH2) gain-of-function (GOF) mutation (EZH2 mutant-type [MT]) and without the EZH2 GOF mutation (EZH2 wild-type [WT]). In Stage 2, EZH2 WT and EZH2 MT patients will be randomly assigned in a 1:1 ratio to tazemetostat + R2 or placebo + R2. There will be 1 futility interim analysis (IA) and 1 efficacy IA for WT population and 1 efficacy IA for MT population.

Stage 3 is a long-term follow-up of patients for assessment of response and overall survival. All patients will be followed for survival until 5 years post last patient enrolled in the study.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 612 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment

Intervention Model Description

3 stages study:

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.

• 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: June 11, 2020
• Estimated Primary Completion Date: September 30, 2029
• Estimated Study Completion Date: April 27, 2032

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: 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.; Other Names: EPZ-6438; IPN60200; Drug: 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.; Other Names: EPZ-6438; IPN60200; Combination Product: 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.; 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; 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.	Drug: 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.; Combination Product: 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.; 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 (RP3D) of tazemetostat in combination with rituximab and lenalidomide (R2) [ Time Frame: Subjects are evaluated for DLTs during the first 28-day cycle. The RP3D for Phase 3 was selected at the end of Stage 1 ]
   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) in the Intent-to-treat wild-type (ITT-WT) population [ Time Frame: Stage 2: 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.
3. PFS in the Intent-to-treat mutant-type (ITT-MT) population [ Time Frame: Stage 2: 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. Pharmacokinetics (PK) of tazemetostat: Maximum (peak) Observed Plasma Drug Concentration (Cmax). [ Time Frame: Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle) ]
   Cmax will be recorded from the PK blood samples collected.
2. PK of tazemetostat, EPZ 6930 (desethyl metabolite), and lenalidomide as data permit: Time to Maximum Observed Drug Concentration (Tmax) [ Time Frame: Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle) ]
3. PK of tazemetostat: area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration [AUC(0-t)], [ Time Frame: Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle) ]
4. PK of tazemetostat: area under the plasma concentration-time curve (AUC) from time 0 to infinity [AUC(0-∞)] [ Time Frame: Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle) ]
5. The apparent terminal elimination half-life (t1/2) of tazemetostat, EPZ 6930 (desethyl metabolite), and lenalidomide as data permit [ Time Frame: Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle) ]
6. Complete Response Rate (CRR) in ITT-WT population [ Time Frame: Stage 2: Up to 96 months ]
   CRR is defined as the proportion of participants achieving CR according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded Independent Review Committee (IRC).
7. CRR in ITT-MT population [ Time Frame: Stage 2: Up to 96 months ]
   CRR is defined as the proportion of participants achieving CR according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC.
8. CRR in the Relapsed/Refractory (R/R) Follicular Lymphoma (FL) population regardless of mutation status [ Time Frame: Stage 2: Up to 96 months ]
   CRR is defined as the proportion of participants achieving CR according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC.
9. Objective Response Rate (ORR) in the ITT-WT population [ Time Frame: Stage 2: Up to 96 months ]
   ORR is defined as the proportion of participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR) according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC.
10. ORR in the ITT-MT population [ Time Frame: Stage 2: Up to 96 months ]
    ORR is defined as the proportion of participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR) according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC.
11. ORR in the R/R FL population regardless of mutation status [ Time Frame: Stage 2: Up to 96 months ]
    ORR is defined as the proportion of participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR) according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC.
12. Overall Survival (OS) in the ITT-WT population [ Time Frame: Stage 2: Up to 96 months ]
    OS is defined as the time from the date of randomization until death due to any cause.
13. OS in the ITT-MT population [ Time Frame: Stage 2: Up to 96 months ]
14. OS in the R/R FL population regardless of mutation status [ Time Frame: Stage 2: Up to 96 months ]
15. PFS in the ITT-WT population, assessed by a blinded IRC [ Time Frame: Stage 2: Up to 96 months ]
16. PFS in the ITT-MT population, assessed by a blinded IRC [ Time Frame: Stage 2: Up to 96 months ]
17. PFS in the R/R FL population regardless of mutation status, assessed by a blinded IRC [ Time Frame: Stage 2: Up to 96 months ]
18. PFS in the R/R FL population regardless of mutation status, assessed by the Investigator [ Time Frame: Stage 2: Up to 96 months ]
19. Duration Of Response (DOR) in the ITT-WT population [ Time Frame: Stage 2: Up to 96 months ]
    DOR is defined as the time from initial CR or PR to documented progression or death due to any cause, whichever occurs first, for those participants with a CR or PR, as assessed by the Investigator and by a blinded IRC.
20. DOR in the ITT-MT population [ Time Frame: Stage 2: Up to 96 months ]
    DOR is defined as the time from initial CR or PR to documented progression or death due to any cause, whichever occurs first, for those participants with a CR or PR, as assessed by the Investigator and by a blinded IRC.
21. DOR in the R/R FL population regardless of mutation status [ Time Frame: Stage 2: Up to 96 months ]
    DOR is defined as the time from initial CR or PR to documented progression or death due to any cause, whichever occurs first, for those participants with a CR or PR, as assessed by the Investigator and by a blinded IRC.
22. Duration Of Complete Response (DOCR) in the ITT-WT population [ Time Frame: Stage 2: Up to 96 months ]
    DOCR is defined as the time from initial CR to documented progression or death due to any cause, whichever occurs first, for those participants with CR, assessed by the Investigator and by a blinded IRC.
23. DOCR in the ITT-MT population [ Time Frame: Stage 2: Up to 96 months ]
    DOCR is defined as the time from initial CR to documented progression or death due to any cause, whichever occurs first, for those participants with CR, assessed by the Investigator and by a blinded IRC.
24. DOCR in the R/R FL population regardless of mutation status [ Time Frame: Stage 2: Up to 96 months ]
    DOCR is defined as the time from initial CR to documented progression or death due to any cause, whichever occurs first, for those participants with CR, assessed by the Investigator and by a blinded IRC.
25. Disease Control Rate (DCR) in the ITT-WT population [ Time Frame: Stage 2: Up to 96 months ]
    DCR, defined as the proportion of participants with best overall response of CR, PR, or stable disease (SD) lasting 12 or more months, as assessed by the Investigator and by a blinded IRC.
26. DCR in the ITT-MT population [ Time Frame: Stage 2: Up to 96 months ]
    DCR, defined as the proportion of participants with best overall response of CR, PR, or stable disease (SD) lasting 12 or more months, as assessed by the Investigator and by a blinded IRC.
27. DCR in the R/R FL population regardless of mutation status [ Time Frame: Stage 2: Up to 96 months ]
    DCR, defined as the proportion of participants with best overall response of CR, PR, or stable disease (SD) lasting 12 or more months, as assessed by the Investigator and by a blinded IRC.
28. Population PK parameters of oral clearance (CL/F) of tazemetostat [ Time Frame: Stage 2: In cycles 2, 4, 6, and 12 at Day 1 (28 days cycle) ]
    CL/F will be used to generate estimates of tazemetostat AUC
29. Population PK parameters of oral volume of distribution (Vd/F) of tazemetostat. [ Time Frame: Stage 2: In cycles 2, 4, 6, and 12 at Day 1 (28 days cycle) ]
30. Population PK parameters of first-order absorption rate constant (Ka) for tazemetostat. [ Time Frame: Stage 2: In cycles 2, 4, 6, and 12 at Day 1 (28 days cycle) ]
31. Percentage of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 36 months ]
    An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
32. Percentage of Participants with Clinically Significant Changes in Physical Examination [ Time Frame: Up to 36 months ]
    Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be graded by the investigator according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 5.0.
33. Percentage of Participants with Clinically Significant Changes in Vital Signs [ Time Frame: Up to 36 months ]
    Percentage of participants with clinically significant changes in vital signs findings will be reported. The clinical significance will be graded by the investigator according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 5.0.
34. Percentage of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Readings [ Time Frame: Up to 72 months ]
    Percentage of participants with clinically significant changes in ECG Readings will be reported. The clinical significance will be graded by the investigator according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 5.0.
35. Performance status evaluated by Eastern Cooperation Oncology Group (ECOG) [ Time Frame: Up to 72 months ]
    ECOG is a 6-point performance status scale used to assess performance using PA as a key indicator (e.g., 0 = fully active, 2 = up and about more than 50% of walking hours, 5 = dead) Performance status will be assessed per usual clinical practice and will be recorded in the medical record.
36. Duration of Study Drug Exposure [ Time Frame: Up to 36 months ]
    Duration of exposure to study drug will be reported.
37. Percentage of study drug taken by participants [ Time Frame: Up to 36 months ]
38. Quality of life questionnaires evaluation [ Time Frame: Up to 36 months ]
    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)

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 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:

   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, 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.

    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 days 14 and 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 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 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 (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. 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.

Contacts and Locations

Contacts

Contact: Ipsen Clinical Study Enquiries; See e mail; clinical.trials@ipsen.com

Locations

United States, Alabama

Southern Cancer Center; Recruiting

Mobile, Alabama, United States, 36608

Contact: Michael Meshad, MD

United States, Arizona

Arizona Oncology Associates - Tuscon-Rusadill Road; Recruiting

Tucson, Arizona, United States, 85704

Contact: Sudhir Manda, MD

United States, California

TOI - Clinical Research; Recruiting

Cerritos, California, United States, 90703

Principal Investigator: Omkar Marathe, MD

UCSF Fresno; Recruiting

Clovis, California, United States, 93611

Contact: Haifaa Abdulhaq, MD

UC San Diego Health Sciences; Recruiting

La Jolla, California, United States, 92093

Contact: Benjamin Heyman

UCLA Clinical Research Unit Hematology/Oncology; Recruiting

Santa Monica, California, United States, 90404

Contact: Sven De Vos, MD

United States, Colorado

Rocky Mountain Cancer Centers (RMCC) - Boulder; Recruiting

Boulder, 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

Cancer Specialists of North Florida; Recruiting

Fleming Island, Florida, United States, 32003

Contact: Mehdi M Moezi, MD

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

Fort Myers, Florida, United States, 33908

Contact: Syed Farhan Zafar, MD

Mayo Clinic - Cancer Clinical Research Office; Withdrawn

Jacksonville, Florida, United States, 32224

Mayo Clinic; Recruiting

Jacksonville, Florida, United States, 32224

Contact: Tan Han, MD

Miami Cancer Institute; Withdrawn

Miami, Florida, United States, 33176

Florida Cancer Affiliates/Ocala Oncology - Clinic; Recruiting

Ocala, Florida, United States, 34474

Contact: Ketan Doshi, MD

BRCR Medical Center, INC; Recruiting

Plantation, Florida, United States, 33322

Contact: Jason Tache, MD

Florida Cancer Specialists; Recruiting

Saint Petersburg, Florida, United States, 33705

Contact: Sunil Gandhi, MD

Florida Cancer Specialists - Panhandle; Recruiting

Tallahassee, Florida, United States, 32308

Principal Investigator: Viralkumar Bhanderi

H Lee Moffitt Cancer Center and Research Institute I; Recruiting

Tampa, Florida, United States, 33612

Contact: Sameh Gaballa, MD

Florida Cancer Specialists & Research Institute (FCS) - Atlantis; Recruiting

West Palm Beach, Florida, United States, 33401

Contact: Shachar Peles, MD

United States, Hawaii

Kaiser Permanente Hawaii Moanalua Medical Center; Withdrawn

Honolulu, Hawaii, United States, 96819

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

June E. Nylen 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.; Withdrawn

Chevy Chase, Maryland, United States, 20815-6908

United States, Massachusetts

Mass General Cancer Center at Newton-Wellesley; Withdrawn

Newton, Massachusetts, United States, 02462

United States, Michigan

University of Michigan Comprehensive Cancer Center; Recruiting

Ann Arbor, Michigan, United States, 48109

Contact: Sano Dahlia, MD

St. Joseph Mercy Hospital; Recruiting

Ypsilanti, Michigan, United States, 48197

Contact: Christopher Reynolds, MD

United States, Minnesota

Mayo Clinic - Rochester; Recruiting

Rochester, Minnesota, United States, 55901

Contact: Jose C Villasboas Bisneto, MD

United States, Missouri

Saint Louis University Cancer Center; 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, 68198

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; Withdrawn

Howell, New Jersey, United States, 07731

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

Weill Cornell Medicine-New York Presbyterian Hospital; Recruiting

New York, New York, United States, 10021

Contact: John P Leonard, MD

Columbia U - Herbert Irving Comprehensive Cancer Center; Recruiting

New York, New York, United States, 10032

Contact: Jennifer Amengual, MD

Memorial Sloan-Kettering Cancer Center; Recruiting

New York, New York, United States, 10065

Principal Investigator: Salles Gilles, 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 - Concord; Recruiting

Concord, North Carolina, United States, 28205

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

Contact: Nashat Gabrail, MD

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

Cincinnati, Ohio, United States, 45236

Contact: Miguel Islas-Ohlmayer, MD

Principal Investigator: Patel Ameet

United States, Oregon

Willamette Valley Cancer Institute and Research Center - Oncology; Recruiting

Eugene, Oregon, United States, 97401

Contact: Jeffrey Sharman, MD

United States, Pennsylvania

University of Pittsburgh Medical Center - Oncology; Withdrawn

Pittsburgh, Pennsylvania, United States, 15232

Western Pennsylvania Hospital Hematology & Cellular Therapy; Recruiting

Pittsburgh, Pennsylvania, United States, 15524

Principal Investigator: Cyrus M Khan, MD

United States, Tennessee

Tennessee Oncology, PLLC; Withdrawn

Chattanooga, Tennessee, United States, 37404

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

Principal Investigator: Ian Flinn

United States, Texas

Texas Oncology - Amarillo; Recruiting

Amarillo, Texas, United States, 79124

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 Physicians - Oncology; Recruiting

Houston, Texas, United States, 77090

Contact: Charles Yen, MD

Texas Oncology; Recruiting

Plano, Texas, United States, 75075

Contact: Charles Connor, MD

Mays Cancer Center; Recruiting

San Antonio, Texas, United States, 78229

Contact: Adolfo Diaz Duque, MD

UT Health East Texas HOPE Cancer Center - Tyler; Recruiting

Tyler, Texas, United States, 75701

Contact: Arielle S Lee, MD

USO Texas Oncology - Tyler; Recruiting

Tyler, Texas, United States, 75702

Contact: Habte A Yimer, MD

Texas Oncology- Weslaco; Recruiting

Weslaco, Texas, United States, 78596

Contact: Daniel Farray-Berges, 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

Peninsula Cancer Institute; Withdrawn

Chesapeake, Virginia, United States, 23320

Virginia Cancer Specialists; Recruiting

Gainesville, Virginia, United States, 22155

Contact: Mitul Gandhi, MD

Oncology and Hematology Associates of Southwest Virginia Inc.; Recruiting

Roanoke, Virginia, United States, 24014

Contact: Amanda Gillespie-Twardy, MD

United States, Washington

MC Rockwood Cancer Bl Specialty Ctr - North; 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; Recruiting

Adelaide, South Australia, Australia, 5000

Contact: Uwe Hahn, MD

Flinders Medical Centre; Recruiting

Bedford Park, South Australia, Australia, 5042

Contact: Lee Hui-Peng, MD

Australia, Victoria

Monash Health; 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; Withdrawn

Yvoir, Namur, Belgium, 5530

Universitair Ziekenhuis Gent; Recruiting

Gent, Oost-Vlaanderen, Belgium, 9000

Contact: Fritz Offner, MD

UZ Leuven - Campus Gasthuisberg; Recruiting

Leuven, Vlaams Brabant, Belgium, 3000

Contact: Ann Janssens, MD

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 3E4

Contact: Stephane Doucet, MD

Sir Mortimer B Davis/Jewish General Hospital; Recruiting

Montréal, Quebec, Canada, H3T 1E2

Contact: Nathalie Johnson, MD

China, Fujian

Fujian Medical University Union Hospital; Recruiting

Fuzhou, Fujian, China, 350001

Contact: Jianzhen Shen, MD

The First Affiliated Hospital of Xiamen University; Recruiting

Xiamen, Fujian, China, 361003

Contact: Bing Xu, MD

China, Guizhou

The Affiliated Hospital of Guizhou Medical University; Recruiting

Guiyang, Guizhou, China, 550004

Contact: Jishi Wang, MD

China, Hangzhou

The Second Affiliated Hospital Zhejiang University School of Medicine; Recruiting

Zhejiang, Hangzhou, China, 310000

Contact: Wenbin Qian, MD

China, Hebei

The Fourth Hospital of Hebei Medical University; Recruiting

Shijiazhuang, Hebei, China, 050011

Contact: Lihong Liu

China, Henan

Henan Provincial People's Hospital; Recruiting

Zhengzhou, Henan, China, 450008

Contact: Zunmin Zhu, MD

Henan Cancer Hospital; Recruiting

Zhengzhou, Henan, China, 45008

Contact: Yufu Li, MD

China, Hunan

Hunan Cancer Hospital; Recruiting

Changsha, Hunan, China, 410013

Contact: Hui Zhou, MD

China, Jinlin

The First Bethune Hospital of Jilin University; Recruiting

Changchun, Jinlin, China, 130021

Contact: Ou Bai, MD

China, Shandong

The Affiliated Hospital of Qingdao University; Recruiting

Qingdao, Shandong, China, 266071

Contact: Hongwei Xue, MD

China, Shanghai

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; Recruiting

Shanghai, Shanghai, China, 20025

Contact: Weili Zhao, MD

China, Shanxi

Shanxi Bethune Hospital; Recruiting

Taiyuan, Shanxi, China, 30032

Contact: Qinghau Zhang, MD

China

Peking University Third Hospital; Recruiting

Beijing, China, 100191

Contact: Hongmei Jing, MD

Tianjin Medical University Cancer Institute & Hospital; Recruiting

Tianjin, China, 300060

Contact: Zhengzi Qian, MD

France

Centre Hospitalier Universitaire de Bordeaux-Hopital du Haut Leveque; Recruiting

Pessac Cedex, Aquitaine, France, 33600

Contact: Krimo Bouabdallah, MD

CHRU Brest Hôp Morvan; Recruiting

Brest, Bretagne, France, 29609

Contact: Adrian Tempescul, MD

Institut Bergonie; Recruiting

Bordeaux, Gironde, France, 33000

Contact: Anna Schmitt, MD

Centre Hosp Mulh Hop Emile Muller; Recruiting

Mulhouse, Haut-Rhin, France, 68100

Contact: Bernard Drenou, MD

Centre Henri Becquerel; Recruiting

Rouen, Haute-Normandie, France, 76038

Principal Investigator: Fabrice Jardin, 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

CHU de Nantes - Hematologie; Recruiting

Nantes, Loire-Atlantique, France, 44000

Principal Investigator: Thomas Gastinne, MD

CHRU de Lille Hop Claude Huriez; Recruiting

Lille, Nord, France, 59037

Contact: Franck Morschhauser, MD

Centre Hospitalier Le Mans; Recruiting

Le Mans, Sarthe, France, 72000

Contact: Kamel Laribi, MD

CHRU de Besançon- Hopital Jean Minjoz; Recruiting

Besancon, France, 25000

Contact: Adrien Chauchet, MD

CHU Caen; Withdrawn

Caen, France, 14000

CHU de Clermont-Ferrand, site Estaing; Recruiting

Clermont-Ferrand, France, 63000

Contact: Steven Le Gouill, MD

L'Hôpital Privé Confluent; Recruiting

Nantes, France, 44202

Hopital Saint Louis; Recruiting

Paris, France, 75010

Contact: Catherine Thieblemont, MD

CHU de Nancy Brabois; Recruiting

Vandœuvre-lès-Nancy, France, 54511

Contact: Pierre Feugier, 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

Klinikum Der Universität München AöR; Recruiting

München, Bayern, Germany, 81377

Contact: Dreyling Martin, MD

Klinikum rechts der Isar der Technischen Universitat Muenche; Withdrawn

München, Bayern, Germany, 81675

Universitätsmedizin Mainz; Recruiting

Mainz, Hessen, Germany, 55131

Contact: Georg Hess, MD

Universitaetsklinikum Bonn AöR; Recruiting

Bonn, Nordrhein-Westfalen, Germany, 53127

Contact: Franz-Georg Bauernfeind, MD

Kliniken Maria Hilf GmbH; Recruiting

Moenchengladbach, Nordrhein-Westfalen, Germany, 41063

Contact: Ullrich Graeven, MD

Städt. Krankenhaus Kiel; Recruiting

Kiel, Schleswig-Holstein, Germany, 24116

Contact: Repp Roland, MD

Hungary

Debreceni Egyetem Klinikai Központ; Recruiting

Debrecen, Hajdú-Bihar, Hungary, 4032

Contact: Arpad Illes, MD

Semmelweis Egyetem Általános Orvostudományi Kar; Recruiting

Budapest, Hungary, 1088

Contact: Zsolt Nagy, MD

Országos Onkológiai Intézet; Recruiting

Budapest, Hungary, 1122

Contact: Tamas Schneider, MD

Del-pesti Centrumkorhaz Orszagos Hematologiai és Infektologiai Intezet; Recruiting

Budapest, Hungary, H-1097

Contact: Gabor Mikala, MD

Italy

AOU Federico II; Recruiting

Napoli, Campania, Italy, 80122

Contact: Fabrizio Pane, MD

Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori IRCCS; Recruiting

Meldola, Forli-Cesena, Italy, 47014

Contact: Gerardo Musuraca, MD

ASST Spedali Civili di Brescia; Recruiting

Brescia, Italy, 25123

Contact: Alessandra Tucci, MD

PO Garibaldi-Nesima, ARNAS Garibaldi; Recruiting

Catania, Italy, 95122

Contact: Ugo Consoli, MD

AOU Careggi; Recruiting

Firenze, Italy, 50134

Contact: Benedetta Puccini, MD

Catholic University Of Sacred Heart; Recruiting

Roma, Italy, 00168

Contact: Stefan Hohaus, MD

Azienda Ospedaliera Santa Maria di Terni; Recruiting

Terni, Italy, 05100

Contact: Anna Marina Liberati, MD

Korea, Republic of

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

Severance Hospital, Yonsei University Health System; Recruiting

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

Contact: Jin Seok Kim, MD

Samsung Medical Center; Recruiting

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

Contact: Won Seog Kim, MD

Seoul National University Hospital; Recruiting

Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080

Contact: Junshik 준식 Hong 홍, MD

Poland

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

Warszawa, Mazowieckie, Poland, 02-781

Contact: Jan Walewski, MD

Centrum Medyczne Pratia Poznan; Recruiting

Skorzewo, Wielkopolskie, Poland, 60-185

Contact: Maciej Kazmierczak, MD

Pratia Onkologia Katowice; Recruiting

Katowice, Poland

Pratia MCM Krakow; Recruiting

Kraków, Poland, 30-727

Contact: Wojciech Jurczak, MD

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

Słupsk, Poland, 76-200

Contact: Wojciech Homenda, MD

MICS Centrum Medyczne Torun; Recruiting

Torun, Poland, 87-100

Contact: Dominik Chraniuk, MD

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

Wroclaw, Poland, 50-367

Contact: Tomasz Wrobel, MD

Spain

Hospital Universitari Vall d'Hebrón; Recruiting

Barcelona, Cataluny, Spain, 08035

Contact: Sabela Bobillo, MD

Hospital Costa del Sol; Recruiting

Marbella, Málaga, Spain, 29603

Contact: Maria Espinosa Casanova, MD

Hospital Del Mar; Recruiting

Barcelona, Spain, 08003

Contact: Antonio Salar Silvestre, 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

Hospital Universitario de Salamanca; 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

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

Kaohsiung, Taiwan, 833

Contact: Ming-Chung 銘崇 Wang 王, MD

Taichung Veterans General Hospital; Recruiting

Taichung, Taiwan, 40705

Contact: Chieh-Lin Teng, 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 - Haematology; Recruiting

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

Contact: Angus Broom, MD

Imperial College Healthcare NHS Trust - Hammersmith Hospital; Recruiting

London, London City, United Kingdom, W12 0HS

Contact: Aristeidis Chaidos, 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

Sponsors and Collaborators

Epizyme, Inc.

Investigators

• Study Director: Ipsen Medical Director; Ipsen

More Information

• Responsible Party: Epizyme, Inc.
• ClinicalTrials.gov Identifier: NCT04224493
• Other Study ID Numbers: EZH-302; 2019-003333-42 ( EudraCT Number )
• First Posted: January 13, 2020
• Last Update Posted: May 8, 2024
• Last Verified: May 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.

Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
• Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
• URL: https://vivli.org/members/ourmembers/

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

Keywords provided by Ipsen ( 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