A Study of Tazemetostat on Safety in Participants With Relapsed or Refractory Follicular Lymphoma With Enhancer of Zeste Homolog 2 (EZH2) Gene Mutation in Japan

December 29, 2025 updated by: Eisai Co., Ltd.

A Post-marketing Observational Study of Tazemetostat on Safety in Patients With Relapsed or Refractory Follicular Lymphoma With EZH2 Gene Mutation in Japan

The primary purpose of the study is to investigate the safety of tazemetostat in participants with relapsed or refractory follicular lymphoma with EZH2 gene mutation under daily clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
145

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
    • Aichi-ken
      • Komaki-shi, Aichi-ken, Japan
        • Eisai Trial Site 131
      • Konan-shi, Aichi-ken, Japan
        • Eisai Trial Site 199
      • Nagakute-shi, Aichi-ken, Japan
        • Eisai Trial Site 21
      • Nagoya, Aichi-ken, Japan
        • Eisai Trial Site 106
      • Nagoya, Aichi-ken, Japan
        • Eisai Trial Site 156
      • Nagoya, Aichi-ken, Japan
        • Eisai Trial Site 174
      • Nagoya, Aichi-ken, Japan
        • Eisai Trial Site 91
      • Okazaki-shi, Aichi-ken, Japan
        • Eisai Trial Site 170
      • Seto-shi, Aichi-ken, Japan
        • Eisai Trial Site 181
      • Toyohashi, Aichi-ken, Japan
        • Eisai Trial Site 130
      • Toyokawa-shi, Aichi-ken, Japan
        • Eisai Trial Site 226
      • Toyota-shi, Aichi-ken, Japan
        • Eisai Trial Site 133
      • Yatomi-shi, Aichi-ken, Japan
        • Eisai Trial Site 205
    • Akita
      • Akita, Akita, Japan
        • Eisai Trial Site 240
    • Aomori
      • Hirosaki-shi, Aomori, Japan
        • Eisai Trial Site 234
      • Hirosaki-shi, Aomori, Japan
        • Eisai Trial Site 96
    • Chiba
      • Chiba, Chiba, Japan
        • Eisai Trial Site 119
      • Kashiwa-shi, Chiba, Japan
        • Eisai Trial Site 5
      • Matsudo-shi, Chiba, Japan
        • Eisai Trial Site 195
    • Ehime
      • Matsuyama, Ehime, Japan
        • Eisai Trial Site 25
    • Fukuoka
      • Fukuoka, Fukuoka, Japan
        • Eisai Trial Site 176
      • Fukuoka, Fukuoka, Japan
        • Eisai Trial Site 227
      • Fukuoka, Fukuoka, Japan
        • Eisai Trial Site 46
      • Iizuka-shi, Fukuoka, Japan
        • Eisai Trial Site 134
      • Kitakyusyu-shi, Fukuoka, Japan
        • Eisai Trial Site 230
    • Fukushima
      • Aizuwakayam-shi, Fukushima, Japan
        • Eisai Trial Site 252
      • Iwaki, Fukushima, Japan
        • Eisai Trial Site 82
      • Koriyama-shi, Fukushima, Japan
        • Eisai Trial Site 244
    • Gifi
      • Ogaki-shi, Gifi, Japan
        • Eisai Trial Site 125
    • Gifu
      • Gifu, Gifu, Japan
        • Eisai Trial Site 27
      • Gifu, Gifu, Japan
        • Eisai Trial Site 28
    • Gunma
      • Fujioka-shi, Gunma, Japan
        • Eisai Trial Site 45
      • Maebashi, Gunma, Japan
        • Eisai Trial Site 224
      • Tatebayashi-shi, Gunma, Japan
        • Eisai Trial Site 235
    • Hiroshima
      • Fukuyama-shi, Hiroshima, Japan
        • Eisai Trial Site 57
      • Hiroshima, Hiroshima, Japan
        • Eisai Trial Site 52
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan
        • Eisai Trial Site 222
      • Kitami-shi, Hokkaido, Japan
        • Eisai Trial Site 198
      • Kushiro, Hokkaido, Japan
        • Eisai Trial Site 71
      • Sapporo, Hokkaido, Japan
        • Eisai Trial Site 167
      • Sapporo, Hokkaido, Japan
        • Eisai Trial Site 183
    • Hyōgo
      • Akashi-shi, Hyōgo, Japan
        • Eisai Trial Site 212
      • Akashi-shi, Hyōgo, Japan
        • Eisai Trial Site 72
      • Amagasaki-shi, Hyōgo, Japan
        • Eisai Trial Site 31
      • Itami-shi, Hyōgo, Japan
        • Eisai Trial Site 124
      • Kobe, Hyōgo, Japan
        • Eisai Trial Site 238
      • Kobe, Hyōgo, Japan
        • Eisai Trial Site 89
      • Kobe, Hyōgo, Japan
        • Eisai Trial Site 93
      • Nishinomiya-shi, Hyōgo, Japan
        • Eisai Trial Site 44
    • Ibaraki
      • Hitachi-shi, Ibaraki, Japan
        • Eisai Trial Site 29
      • Toride-shi, Ibaraki, Japan
        • Eisai Trial Site 237
    • Kagawa-ken
      • Takamatsu, Kagawa-ken, Japan
        • Eisai Trial Site 105
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan
        • Eisai Trial Site 118
      • Kanoya-shi, Kagoshima-ken, Japan
        • Eisai Trial Site 207
    • Kanagawa
      • Ebina-shi, Kanagawa, Japan
        • Eisai Trial Site 109
      • Kawasaki-shi, Kanagawa, Japan
        • EISAI Trial Site 17
      • Kawasaki-shi, Kanagawa, Japan
        • Eisai Trial Site 190
      • Sagamihara-shi, Kanagawa, Japan
        • Eisai Trial Site 87
      • Yokohama, Kanagawa, Japan
        • Eisai Trial Site 177
      • Yokohama, Kanagawa, Japan
        • Eisai Trial Site 43
      • Yokosuka-shi, Kanagawa, Japan
        • Eisai Trial Site 169
    • Kochi
      • Nankoku-shi, Kochi, Japan
        • Eisai Trial Site 9
    • Kumamoto
      • Kumamoto, Kumamoto, Japan
        • Eisai Trial Site 253
      • Kumamoto, Kumamoto, Japan
        • Eisai Trial Site 55
    • Kyoto
      • Kyoto, Kyoto, Japan
        • Eisai Trial Site 26
      • Kyoto, Kyoto, Japan
        • Eisai Trial Site 4
      • Kyoto, Kyoto, Japan
        • Eisai Trial Site 56
      • Kyoto, Kyoto, Japan
        • Eisai Trial Site 76
    • Mie-ken
      • Matsusaka-shi, Mie-ken, Japan
        • Eisai Trial Site 122
      • Matsusaka-shi, Mie-ken, Japan
        • Eisai Trial Site 36
      • Yokkaichi-shi, Mie-ken, Japan
        • Eisai Trial Site 186
    • Miyagi
      • Osaki-shi, Miyagi, Japan
        • Eisai Trial Site 242
      • Sendai, Miyagi, Japan
        • Eisai Trial Site 161
    • Miyazaki
      • Nobeoka-shi, Miyazaki, Japan
        • Eisai Trial Site 189
    • Nagano
      • Matsumoto-shi, Nagano, Japan
        • Eisai Trial Site 192
      • Matsumoto-shi, Nagano, Japan
        • Eisai Trial Site 208
    • Nagasaki
      • Nagasaki, Nagasaki, Japan
        • Eisai Trial Site 127
    • Nara
      • Kashihara-shi, Nara, Japan
        • Eisai Trial Site 251
    • Okayama-ken
      • Maniwa-shi, Okayama-ken, Japan
        • Eisai Trial Site 2
      • Okayama, Okayama-ken, Japan
        • Eisai Trial Site 12
      • Okayama, Okayama-ken, Japan
        • EISAI Trial Site 14
      • Okayama, Okayama-ken, Japan
        • Eisai Trial Site 178
      • Okayama, Okayama-ken, Japan
        • Eisai Trial Site 41
    • Okinawa
      • Nakagami-gun, Okinawa, Japan
        • EISAI Trial Site 18
      • Okinawa-shi, Okinawa, Japan
        • Eisai Trial Site 204
    • Osaka
      • Hirakata-shi, Osaka, Japan
        • Eisai Trial Site 164
      • Izumisano, Osaka, Japan
        • Eisai Trial Site 49
      • Kawachinagano-shi, Osaka, Japan
        • Eisai Trial Site 239
      • Kawachinagano-shi, Osaka, Japan
        • Eisai Trial Site 59
      • Osaka, Osaka, Japan
        • Eisai Trial Site 144
      • Osaka, Osaka, Japan
        • Eisai Trial Site 165
      • Osaka, Osaka, Japan
        • Eisai Trial Site 179
      • Osaka, Osaka, Japan
        • Eisai Trial Site 213
      • Osaka, Osaka, Japan
        • Eisai Trial Site 220
      • Osaka, Osaka, Japan
        • Eisai Trial Site 228
      • Osaka, Osaka, Japan
        • Eisai Trial Site 60
      • Sakai-shi, Osaka, Japan
        • Eisai Trial Site 221
      • Takatsuki-shi, Osaka, Japan
        • Eisai Trial Site 233
      • Toyonaka-shi, Osaka, Japan
        • Eisai Trial Site 98
    • Saga-ken
      • Saga, Saga-ken, Japan
        • Eisai Trial Site 247
    • Saitama
      • Ageo-shi, Saitama, Japan
        • Eisai Trial Site 254
      • Hidaka-shi, Saitama, Japan
        • Eisai Trial Site 148
      • Saitama-shi, Saitama, Japan
        • Eisai Trial Site 152
      • Saitama-shi, Saitama, Japan
        • Eisai Trial Site 197
      • Tokorozawa-shi, Saitama, Japan
        • Eisai Trial Site 140
    • Shiga
      • Ōtsu, Shiga, Japan
        • Eisai Trial Site 175
    • Shizuoka
      • Iwata-shi, Shizuoka, Japan
        • Eisai Trial Site 223
      • Izunokuni-shi, Shizuoka, Japan
        • Eisai Trial Site 40
      • Shizuoka, Shizuoka, Japan
        • Eisai Trial Site 88
    • Tochigi
      • Shimotsuke-shi, Tochigi, Japan
        • Eisai Trial Site 201
      • Shimotsuke-shi, Tochigi, Japan
        • Eisai Trial Site 245
    • Tokushima
      • Komatsushima-shi, Tokushima, Japan
        • Eisai Trial Site 243
      • Tokushima, Tokushima, Japan
        • Eisai Trial Site 101
      • Tokushima, Tokushima, Japan
        • Eisai Trial Site 187
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • Eisai Trial Site 158
      • Bunkyo-ku, Tokyo, Japan
        • Eisai Trial Site 193
      • Chiyoda-ku, Tokyo, Japan
        • Eisai Trial Site 225
      • Chofu-shi, Tokyo, Japan
        • Eisai Trial Site 241
      • Chuo-ku, Tokyo, Japan
        • Eisai Trial Site 1
      • Edogawa-ku, Tokyo, Japan
        • Eisai Trial Site 107
      • Kita-ku, Tokyo, Japan
        • Eisai Trial Site 249
      • Meguro-ku, Tokyo, Japan
        • Eisai Trial Site 229
      • Minato-ku, Tokyo, Japan
        • Eisai Trial Site 50
      • Shinagawa-Ku, Tokyo, Japan
        • Eisai Trial Site 24
      • Shinjuku-ku, Tokyo, Japan
        • Eisai Trial Site 162
      • Shinjuku-ku, Tokyo, Japan
        • Eisai Trial Site 248
      • Suginami-ku, Tokyo, Japan
        • Eisai Trial Site 159
      • Taito-ku, Tokyo, Japan
        • Eisai Trial Site 231
      • Toshima-ku, Tokyo, Japan
        • Eisai Trial Site 202
    • Tottori
      • Yonago-shi, Tottori, Japan
        • Eisai Trial Site 83
    • Toyama
      • Toyama, Toyama, Japan
        • Eisai Trial Site 188
      • Toyama, Toyama, Japan
        • Eisai Trial Site 246
    • Wakayama
      • Tanabe-shi, Wakayama, Japan
        • Eisai Trial Site 142
      • Wakayama, Wakayama, Japan
        • Eisai Trial Site 236
    • Yamagata
      • Sakata-shi, Yamagata, Japan
        • Eisai Trial Site 20

Participation Criteria

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

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants with relapsed or refractory follicular lymphoma with EZH2 gene mutation will be enrolled in this study.

Description

Inclusion Criteria:

  1. Participants with relapsed or refractory follicular lymphoma with EZH2 gene mutation
  2. Participants treated with tazemetostat

Exclusion Criteria:

1. Participants with a history of hypersensitivity to any ingredient of Tazverik

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Tazemetostat
Participants with relapsed or refractory follicular lymphoma with EZH2 gene mutation will receive Tazemetostat 800 milligram (mg), tablet, orally, twice daily or as per physicians discretion in routine clinical practice. All the participants will be observed for up to Week 52 prospectively.
Drug: Tazemetostat
Tazemetostat oral tablets.
Other Names:
  • Tazverik

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Drug Reactions (ADRs)
Time Frame: Up to Week 52
An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. Adverse events (AEs) with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
Up to Week 52
Number of Participants With Serious ADRs
Time Frame: Up to Week 52
Serious ADRs are defined as any untoward medical occurrence or effect that at any dose resulted in death or life-threatening conditions or required hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect or medically important condition.
Up to Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With ADRs Based on Participant Background Factors
Time Frame: Up to Week 52
Number of participants with ADRs such as myelosuppression and infection based on participants background factors will be reported. Participant background factors will be sex, age, height, weight, clinical stage (Ann Arbor classification), the presence or absence of B symptoms, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), complications, past history and history of drug allergy.
Up to Week 52
Percentage of Participants with Overall Response
Time Frame: Up to Week 52
Overall response rate is defined as a percentage of participants who achieved a best response including complete response (CR) or partial response (PR) based on Revised Response Criteria for Malignant Lymphoma (Cheson, 2007). CR: defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.
Up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai Co., Ltd.

Study record dates

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

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E7438-M081-501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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