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

NCT05228158 | Active Not Recruiting FDA Drug

• 1 other identifier: E7438-M081-501
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 135

Brief 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.

Conditions

Lymphoma, Follicular

Keywords

E7438; Tazemetostat; Tazverik

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to Week 52

• 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.

  Up to Week 52

Secondary Outcomes (2)

• Number of Participants With ADRs Based on Participant Background Factors

  Up to Week 52

• Percentage of Participants with Overall Response

  Up to Week 52

Study Arms (1)

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

Interventions

Tazemetostat DRUG

Tazemetostat oral tablets.

Also known as: Tazverik

Tazemetostat

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (135)

Eisai Trial Site 131

Komaki-shi, Aichi-ken, Japan

Location

Eisai Trial Site 199

Konan-shi, Aichi-ken, Japan

Location

Eisai Trial Site 21

Nagakute-shi, Aichi-ken, Japan

Location

Eisai Trial Site 106

Nagoya, Aichi-ken, Japan

Location

Eisai Trial Site 156

Nagoya, Aichi-ken, Japan

Location

Eisai Trial Site 174

Nagoya, Aichi-ken, Japan

Location

Eisai Trial Site 91

Nagoya, Aichi-ken, Japan

Location

Eisai Trial Site 170

Okazaki-shi, Aichi-ken, Japan

Location

Eisai Trial Site 181

Seto-shi, Aichi-ken, Japan

Location

Eisai Trial Site 130

Toyohashi, Aichi-ken, Japan

Location

Eisai Trial Site 226

Toyokawa-shi, Aichi-ken, Japan

Location

Eisai Trial Site 133

Toyota-shi, Aichi-ken, Japan

Location

Eisai Trial Site 205

Yatomi-shi, Aichi-ken, Japan

Location

Eisai Trial Site 240

Akita, Akita, Japan

Location

Eisai Trial Site 234

Hirosaki-shi, Aomori, Japan

Location

Eisai Trial Site 96

Hirosaki-shi, Aomori, Japan

Location

Eisai Trial Site 119

Chiba, Chiba, Japan

Location

Eisai Trial Site 5

Kashiwa-shi, Chiba, Japan

Location

Eisai Trial Site 195

Matsudo-shi, Chiba, Japan

Location

Eisai Trial Site 25

Matsuyama, Ehime, Japan

Location

Eisai Trial Site 176

Fukuoka, Fukuoka, Japan

Location

Eisai Trial Site 227

Fukuoka, Fukuoka, Japan

Location

Eisai Trial Site 46

Fukuoka, Fukuoka, Japan

Location

Eisai Trial Site 134

Iizuka-shi, Fukuoka, Japan

Location

Eisai Trial Site 230

Kitakyusyu-shi, Fukuoka, Japan

Location

Eisai Trial Site 252

Aizuwakayam-shi, Fukushima, Japan

Location

Eisai Trial Site 82

Iwaki, Fukushima, Japan

Location

Eisai Trial Site 244

Koriyama-shi, Fukushima, Japan

Location

Eisai Trial Site 125

Ogaki-shi, Gifi, Japan

Location

Eisai Trial Site 27

Gifu, Gifu, Japan

Location

Eisai Trial Site 28

Gifu, Gifu, Japan

Location

Eisai Trial Site 45

Fujioka-shi, Gunma, Japan

Location

Eisai Trial Site 224

Maebashi, Gunma, Japan

Location

Eisai Trial Site 235

Tatebayashi-shi, Gunma, Japan

Location

Eisai Trial Site 57

Fukuyama-shi, Hiroshima, Japan

Location

Eisai Trial Site 52

Hiroshima, Hiroshima, Japan

Location

Eisai Trial Site 222

Asahikawa-shi, Hokkaido, Japan

Location

Eisai Trial Site 198

Kitami-shi, Hokkaido, Japan

Location

Eisai Trial Site 71

Kushiro, Hokkaido, Japan

Location

Eisai Trial Site 167

Sapporo, Hokkaido, Japan

Location

Eisai Trial Site 183

Sapporo, Hokkaido, Japan

Location

Eisai Trial Site 212

Akashi-shi, Hyōgo, Japan

Location

Eisai Trial Site 72

Akashi-shi, Hyōgo, Japan

Location

Eisai Trial Site 31

Amagasaki-shi, Hyōgo, Japan

Location

Eisai Trial Site 124

Itami-shi, Hyōgo, Japan

Location

Eisai Trial Site 238

Kobe, Hyōgo, Japan

Location

Eisai Trial Site 89

Kobe, Hyōgo, Japan

Location

Eisai Trial Site 93

Kobe, Hyōgo, Japan

Location

Eisai Trial Site 44

Nishinomiya-shi, Hyōgo, Japan

Location

Eisai Trial Site 29

Hitachi-shi, Ibaraki, Japan

Location

Eisai Trial Site 237

Toride-shi, Ibaraki, Japan

Location

Eisai Trial Site 105

Takamatsu, Kagawa-ken, Japan

Location

Eisai Trial Site 118

Kagoshima, Kagoshima-ken, Japan

Location

Eisai Trial Site 207

Kanoya-shi, Kagoshima-ken, Japan

Location

Eisai Trial Site 109

Ebina-shi, Kanagawa, Japan

Location

Eisai Trial Site 17

Kawasaki-shi, Kanagawa, Japan

Location

Eisai Trial Site 190

Kawasaki-shi, Kanagawa, Japan

Location

Eisai Trial Site 87

Sagamihara-shi, Kanagawa, Japan

Location

Eisai Trial Site 177

Yokohama, Kanagawa, Japan

Location

Eisai Trial Site 43

Yokohama, Kanagawa, Japan

Location

Eisai Trial Site 169

Yokosuka-shi, Kanagawa, Japan

Location

Eisai Trial Site 9

Nankoku-shi, Kochi, Japan

Location

Eisai Trial Site 253

Kumamoto, Kumamoto, Japan

Location

Eisai Trial Site 55

Kumamoto, Kumamoto, Japan

Location

Eisai Trial Site 26

Kyoto, Kyoto, Japan

Location

Eisai Trial Site 4

Kyoto, Kyoto, Japan

Location

Eisai Trial Site 56

Kyoto, Kyoto, Japan

Location

Eisai Trial Site 76

Kyoto, Kyoto, Japan

Location

Eisai Trial Site 122

Matsusaka-shi, Mie-ken, Japan

Location

Eisai Trial Site 36

Matsusaka-shi, Mie-ken, Japan

Location

Eisai Trial Site 186

Yokkaichi-shi, Mie-ken, Japan

Location

Eisai Trial Site 242

Osaki-shi, Miyagi, Japan

Location

Eisai Trial Site 161

Sendai, Miyagi, Japan

Location

Eisai Trial Site 189

Nobeoka-shi, Miyazaki, Japan

Location

Eisai Trial Site 192

Matsumoto-shi, Nagano, Japan

Location

Eisai Trial Site 208

Matsumoto-shi, Nagano, Japan

Location

Eisai Trial Site 127

Nagasaki, Nagasaki, Japan

Location

Eisai Trial Site 251

Kashihara-shi, Nara, Japan

Location

Eisai Trial Site 2

Maniwa-shi, Okayama-ken, Japan

Location

Eisai Trial Site 12

Okayama, Okayama-ken, Japan

Location

Eisai Trial Site 14

Okayama, Okayama-ken, Japan

Location

Eisai Trial Site 178

Okayama, Okayama-ken, Japan

Location

Eisai Trial Site 41

Okayama, Okayama-ken, Japan

Location

Eisai Trial Site 18

Nakagami-gun, Okinawa, Japan

Location

Eisai Trial Site 204

Okinawa-shi, Okinawa, Japan

Location

Eisai Trial Site 164

Hirakata-shi, Osaka, Japan

Location

Eisai Trial Site 49

Izumisano, Osaka, Japan

Location

Eisai Trial Site 239

Kawachinagano-shi, Osaka, Japan

Location

Eisai Trial Site 59

Kawachinagano-shi, Osaka, Japan

Location

Eisai Trial Site 144

Osaka, Osaka, Japan

Location

Eisai Trial Site 165

Osaka, Osaka, Japan

Location

Eisai Trial Site 179

Osaka, Osaka, Japan

Location

Eisai Trial Site 213

Osaka, Osaka, Japan

Location

Eisai Trial Site 220

Osaka, Osaka, Japan

Location

Eisai Trial Site 228

Osaka, Osaka, Japan

Location

Eisai Trial Site 60

Osaka, Osaka, Japan

Location

Eisai Trial Site 221

Sakai-shi, Osaka, Japan

Location

Eisai Trial Site 233

Takatsuki-shi, Osaka, Japan

Location

Eisai Trial Site 98

Toyonaka-shi, Osaka, Japan

Location

Eisai Trial Site 247

Saga, Saga-ken, Japan

Location

Eisai Trial Site 254

Ageo-shi, Saitama, Japan

Location

Eisai Trial Site 148

Hidaka-shi, Saitama, Japan

Location

Eisai Trial Site 152

Saitama-shi, Saitama, Japan

Location

Eisai Trial Site 197

Saitama-shi, Saitama, Japan

Location

Eisai Trial Site 140

Tokorozawa-shi, Saitama, Japan

Location

Eisai Trial Site 175

Ōtsu, Shiga, Japan

Location

Eisai Trial Site 223

Iwata-shi, Shizuoka, Japan

Location

Eisai Trial Site 40

Izunokuni-shi, Shizuoka, Japan

Location

Eisai Trial Site 88

Shizuoka, Shizuoka, Japan

Location

Eisai Trial Site 201

Shimotsuke-shi, Tochigi, Japan

Location

Eisai Trial Site 245

Shimotsuke-shi, Tochigi, Japan

Location

Eisai Trial Site 243

Komatsushima-shi, Tokushima, Japan

Location

Eisai Trial Site 101

Tokushima, Tokushima, Japan

Location

Eisai Trial Site 187

Tokushima, Tokushima, Japan

Location

Eisai Trial Site 158

Bunkyo-ku, Tokyo, Japan

Location

Eisai Trial Site 193

Bunkyo-ku, Tokyo, Japan

Location

Eisai Trial Site 225

Chiyoda-ku, Tokyo, Japan

Location

Eisai Trial Site 241

Chofu-shi, Tokyo, Japan

Location

Eisai Trial Site 1

Chuo-ku, Tokyo, Japan

Location

Eisai Trial Site 107

Edogawa-ku, Tokyo, Japan

Location

Eisai Trial Site 249

Kita-ku, Tokyo, Japan

Location

Eisai Trial Site 229

Meguro-ku, Tokyo, Japan

Location

Eisai Trial Site 50

Minato-ku, Tokyo, Japan

Location

Eisai Trial Site 24

Shinagawa-Ku, Tokyo, Japan

Location

Eisai Trial Site 162

Shinjuku-ku, Tokyo, Japan

Location

Eisai Trial Site 248

Shinjuku-ku, Tokyo, Japan

Location

Eisai Trial Site 159

Suginami-ku, Tokyo, Japan

Location

Eisai Trial Site 231

Taito-ku, Tokyo, Japan

Location

Eisai Trial Site 202

Toshima-ku, Tokyo, Japan

Location

Eisai Trial Site 83

Yonago-shi, Tottori, Japan

Location

Eisai Trial Site 188

Toyama, Toyama, Japan

Location

Eisai Trial Site 246

Toyama, Toyama, Japan

Location

Eisai Trial Site 142

Tanabe-shi, Wakayama, Japan

Location

Eisai Trial Site 236

Wakayama, Wakayama, Japan

Location

Eisai Trial Site 20

Sakata-shi, Yamagata, Japan

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

tazemetostat

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 8, 2022
• Study Start: August 16, 2021
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

JP (135)