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Lymphoma, FollicularNCT05228158

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

An observational study of Lymphoma, Follicular, run by Eisai Co., Ltd. at 135 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Lymphoma, Follicular
What is being tested?
Tazemetostat
Type of treatment
Pill or oral medicine
How many people
145 participants
Where
135 sitesJapan
Study dates
16 Aug 2021to 31 Mar 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • Participants with relapsed or refractory follicular lymphoma with EZH2 gene mutation
  • Participants treated with tazemetostat

Who cannot join

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

Trial locations and contacts

135 sites in 1 country.

135 sites in 1 country

Japan135 sites

  • Eisai Trial Site 254

    Ageo-shi, Saitama

  • Eisai Trial Site 252

    Aizuwakayam-shi, Fukushima

  • Eisai Trial Site 212

    Akashi-shi, Hyōgo

  • Eisai Trial Site 72

    Akashi-shi, Hyōgo

  • Eisai Trial Site 240

    Akita, Akita

  • Eisai Trial Site 31

    Amagasaki-shi, Hyōgo

  • Eisai Trial Site 222

    Asahikawa-shi, Hokkaido

  • Eisai Trial Site 158

    Bunkyo-ku, Tokyo

  • Eisai Trial Site 193

    Bunkyo-ku, Tokyo

  • Eisai Trial Site 119

    Chiba, Chiba

  • Eisai Trial Site 225

    Chiyoda-ku, Tokyo

  • Eisai Trial Site 241

    Chofu-shi, Tokyo

  • Eisai Trial Site 1

    Chuo-ku, Tokyo

  • Eisai Trial Site 109

    Ebina-shi, Kanagawa

  • Eisai Trial Site 107

    Edogawa-ku, Tokyo

  • Eisai Trial Site 45

    Fujioka-shi, Gunma

  • Eisai Trial Site 176

    Fukuoka, Fukuoka

  • Eisai Trial Site 227

    Fukuoka, Fukuoka

  • Eisai Trial Site 46

    Fukuoka, Fukuoka

  • Eisai Trial Site 57

    Fukuyama-shi, Hiroshima

  • Eisai Trial Site 27

    Gifu, Gifu

  • Eisai Trial Site 28

    Gifu, Gifu

  • Eisai Trial Site 148

    Hidaka-shi, Saitama

  • Eisai Trial Site 164

    Hirakata-shi, Osaka

  • Eisai Trial Site 234

    Hirosaki-shi, Aomori

  • Eisai Trial Site 96

    Hirosaki-shi, Aomori

  • Eisai Trial Site 52

    Hiroshima, Hiroshima

  • Eisai Trial Site 29

    Hitachi-shi, Ibaraki

  • Eisai Trial Site 134

    Iizuka-shi, Fukuoka

  • Eisai Trial Site 124

    Itami-shi, Hyōgo

  • Eisai Trial Site 82

    Iwaki, Fukushima

  • Eisai Trial Site 223

    Iwata-shi, Shizuoka

  • Eisai Trial Site 49

    Izumisano, Osaka

  • Eisai Trial Site 40

    Izunokuni-shi, Shizuoka

  • Eisai Trial Site 118

    Kagoshima, Kagoshima-ken

  • Eisai Trial Site 207

    Kanoya-shi, Kagoshima-ken

  • Eisai Trial Site 251

    Kashihara-shi, Nara

  • Eisai Trial Site 5

    Kashiwa-shi, Chiba

  • Eisai Trial Site 239

    Kawachinagano-shi, Osaka

  • Eisai Trial Site 59

    Kawachinagano-shi, Osaka

  • Eisai Trial Site 17

    Kawasaki-shi, Kanagawa

  • Eisai Trial Site 190

    Kawasaki-shi, Kanagawa

  • Eisai Trial Site 249

    Kita-ku, Tokyo

  • Eisai Trial Site 230

    Kitakyusyu-shi, Fukuoka

  • Eisai Trial Site 198

    Kitami-shi, Hokkaido

  • Eisai Trial Site 238

    Kobe, Hyōgo

  • Eisai Trial Site 89

    Kobe, Hyōgo

  • Eisai Trial Site 93

    Kobe, Hyōgo

  • Eisai Trial Site 131

    Komaki-shi, Aichi-ken

  • Eisai Trial Site 243

    Komatsushima-shi, Tokushima

  • Eisai Trial Site 199

    Konan-shi, Aichi-ken

  • Eisai Trial Site 244

    Koriyama-shi, Fukushima

  • Eisai Trial Site 253

    Kumamoto, Kumamoto

  • Eisai Trial Site 55

    Kumamoto, Kumamoto

  • Eisai Trial Site 71

    Kushiro, Hokkaido

  • Eisai Trial Site 26

    Kyoto, Kyoto

  • Eisai Trial Site 4

    Kyoto, Kyoto

  • Eisai Trial Site 56

    Kyoto, Kyoto

  • Eisai Trial Site 76

    Kyoto, Kyoto

  • Eisai Trial Site 224

    Maebashi, Gunma

  • Eisai Trial Site 2

    Maniwa-shi, Okayama-ken

  • Eisai Trial Site 195

    Matsudo-shi, Chiba

  • Eisai Trial Site 192

    Matsumoto-shi, Nagano

  • Eisai Trial Site 208

    Matsumoto-shi, Nagano

  • Eisai Trial Site 122

    Matsusaka-shi, Mie-ken

  • Eisai Trial Site 36

    Matsusaka-shi, Mie-ken

  • Eisai Trial Site 25

    Matsuyama, Ehime

  • Eisai Trial Site 229

    Meguro-ku, Tokyo

  • Eisai Trial Site 50

    Minato-ku, Tokyo

  • Eisai Trial Site 21

    Nagakute-shi, Aichi-ken

  • Eisai Trial Site 127

    Nagasaki, Nagasaki

  • Eisai Trial Site 106

    Nagoya, Aichi-ken

  • Eisai Trial Site 156

    Nagoya, Aichi-ken

  • Eisai Trial Site 174

    Nagoya, Aichi-ken

  • Eisai Trial Site 91

    Nagoya, Aichi-ken

  • Eisai Trial Site 18

    Nakagami-gun, Okinawa

  • Eisai Trial Site 9

    Nankoku-shi, Kochi

  • Eisai Trial Site 44

    Nishinomiya-shi, Hyōgo

  • Eisai Trial Site 189

    Nobeoka-shi, Miyazaki

  • Eisai Trial Site 125

    Ogaki-shi, Gifi

  • Eisai Trial Site 12

    Okayama, Okayama-ken

  • Eisai Trial Site 14

    Okayama, Okayama-ken

  • Eisai Trial Site 178

    Okayama, Okayama-ken

  • Eisai Trial Site 41

    Okayama, Okayama-ken

  • Eisai Trial Site 170

    Okazaki-shi, Aichi-ken

  • Eisai Trial Site 204

    Okinawa-shi, Okinawa

  • Eisai Trial Site 144

    Osaka, Osaka

  • Eisai Trial Site 165

    Osaka, Osaka

  • Eisai Trial Site 179

    Osaka, Osaka

  • Eisai Trial Site 213

    Osaka, Osaka

  • Eisai Trial Site 220

    Osaka, Osaka

  • Eisai Trial Site 228

    Osaka, Osaka

  • Eisai Trial Site 60

    Osaka, Osaka

  • Eisai Trial Site 242

    Osaki-shi, Miyagi

  • Eisai Trial Site 175

    Ōtsu, Shiga

  • Eisai Trial Site 247

    Saga, Saga-ken

  • Eisai Trial Site 87

    Sagamihara-shi, Kanagawa

  • Eisai Trial Site 152

    Saitama-shi, Saitama

  • Eisai Trial Site 197

    Saitama-shi, Saitama

  • Eisai Trial Site 221

    Sakai-shi, Osaka

  • Eisai Trial Site 20

    Sakata-shi, Yamagata

  • Eisai Trial Site 167

    Sapporo, Hokkaido

  • Eisai Trial Site 183

    Sapporo, Hokkaido

  • Eisai Trial Site 161

    Sendai, Miyagi

  • Eisai Trial Site 181

    Seto-shi, Aichi-ken

  • Eisai Trial Site 201

    Shimotsuke-shi, Tochigi

  • Eisai Trial Site 245

    Shimotsuke-shi, Tochigi

  • Eisai Trial Site 24

    Shinagawa-Ku, Tokyo

  • Eisai Trial Site 162

    Shinjuku-ku, Tokyo

  • Eisai Trial Site 248

    Shinjuku-ku, Tokyo

  • Eisai Trial Site 88

    Shizuoka, Shizuoka

  • Eisai Trial Site 159

    Suginami-ku, Tokyo

  • Eisai Trial Site 231

    Taito-ku, Tokyo

  • Eisai Trial Site 105

    Takamatsu, Kagawa-ken

  • Eisai Trial Site 233

    Takatsuki-shi, Osaka

  • Eisai Trial Site 142

    Tanabe-shi, Wakayama

  • Eisai Trial Site 235

    Tatebayashi-shi, Gunma

  • Eisai Trial Site 140

    Tokorozawa-shi, Saitama

  • Eisai Trial Site 101

    Tokushima, Tokushima

  • Eisai Trial Site 187

    Tokushima, Tokushima

  • Eisai Trial Site 237

    Toride-shi, Ibaraki

  • Eisai Trial Site 202

    Toshima-ku, Tokyo

  • Eisai Trial Site 188

    Toyama, Toyama

  • Eisai Trial Site 246

    Toyama, Toyama

  • Eisai Trial Site 130

    Toyohashi, Aichi-ken

  • Eisai Trial Site 226

    Toyokawa-shi, Aichi-ken

  • Eisai Trial Site 98

    Toyonaka-shi, Osaka

  • Eisai Trial Site 133

    Toyota-shi, Aichi-ken

  • Eisai Trial Site 236

    Wakayama, Wakayama

  • Eisai Trial Site 205

    Yatomi-shi, Aichi-ken

  • Eisai Trial Site 186

    Yokkaichi-shi, Mie-ken

  • Eisai Trial Site 177

    Yokohama, Kanagawa

  • Eisai Trial Site 43

    Yokohama, Kanagawa

  • Eisai Trial Site 169

    Yokosuka-shi, Kanagawa

  • Eisai Trial Site 83

    Yonago-shi, Tottori

Other trials in Japan

About this study

Official title: 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.

Being tested
Tazemetostat
Keywords
E7438, Tazemetostat, Tazverik
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TazemetostatDrug

    Also called Tazverik

    Tazemetostat oral tablets.

Study groups in NCT05228158
Study groupRoleWhat they receive
TazemetostatParticipants 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.
Receives: Drug: Tazemetostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Drug Reactions (ADRs)

    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.

    Measured: Up to Week 52

  2. Number of Participants With Serious ADRs

    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.

    Measured: Up to Week 52

Secondary outcomes (2)

  1. Number of Participants With ADRs Based on Participant Background Factors

    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.

    Measured: Up to Week 52

  2. Percentage of Participants with Overall Response

    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.

    Measured: Up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2022
  2. Study start16 Aug 2021
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
145 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05228158
Sponsor's protocol ID
E7438-M081-501
Status last verified
Dec 2025
First submitted
27 Jan 2022
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphoma, Follicular, run by Eisai Co., Ltd. at 135 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Drug Reactions (ADRs) (time frame: Up to Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05228158.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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