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
- Registration Number
- NCT05228158
- Lead Sponsor
- Eisai Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 145
- Participants with relapsed or refractory follicular lymphoma with EZH2 gene mutation
- Participants treated with tazemetostat
- Participants with a history of hypersensitivity to any ingredient of Tazverik
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tazemetostat 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Drug Reactions (ADRs) 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.
Number of Participants With Serious ADRs 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Overall Response 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.
Number of Participants With ADRs Based on Participant Background Factors 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.
Trial Locations
- Locations (228)
Eisai Trial Site 216
🇯🇵Yatomi-shi, Aichi, Japan
Eisai Trial Site 206
🇯🇵Matsudo-shi, Chiba, Japan
Eisai Trial Site 240
🇯🇵Fukuoka-shi, Fukuoka, Japan
Eisai Trial Site 243
🇯🇵Kitakyusyu-shi, Fukuoka, Japan
Eisai Trial Site 245
🇯🇵Kurume-shi, Fukuoka, Japan
Eisai Trial Site 236
🇯🇵Maebashi-shi, Gumma, Japan
Eisai Trial Site 204
🇯🇵Bunkyo-ku, Tokyo, Japan
Eisai Trial Site 237
🇯🇵Chiyoda-ku, Tokyo, Japan
Eisai Trial Site 242
🇯🇵Meguro-ku, Tokyo, Japan
Eisai Trial Site 191
🇯🇵Ota-ku, Tokyo, Japan
Eisai Trial Site 244
🇯🇵Taito-ku, Tokyo, Japan
Eisai Trial Site 213
🇯🇵Toshima-ku, Tokyo, Japan
Eisai Trial Site 199
🇯🇵Toyama-shi, Toyama, Japan
Eisai Trial Site 214
🇯🇵Ube-shi, Yamaguchi, Japan
Eisai Trial Site 172
🇯🇵Anjo-shi, Aichi, Japan
Eisai Trial Site 129
🇯🇵Komaki-shi, Aichi, Japan
Eisai Trial Site 20
🇯🇵Nagakute-shi, Aichi, Japan
Eisai Trial Site 105
🇯🇵Nagoya-shi, Aichi, Japan
Eisai Trial Site 152
🇯🇵Nagoya-shi, Aichi, Japan
Eisai Trial Site 163
🇯🇵Nagoya-shi, Aichi, Japan
Eisai Trial Site 168
🇯🇵Nagoya-shi, Aichi, Japan
Eisai Trial Site 90
🇯🇵Nagoya-shi, Aichi, Japan
Eisai Trial Site 13
🇯🇵Okayama-shi, Okayama, Japan
Eisai Trial Site 170
🇯🇵Okayama-shi, Okayama, Japan
Eisai Trial Site 126
🇯🇵Mitaka-shi, Tokyo, Japan
Eisai Trial Site 89
🇯🇵Musashino-shi, Tokyo, Japan
Eisai Trial Site 158
🇯🇵Shinjuku-ku, Tokyo, Japan
Eisai Trial Site 80
🇯🇵Shinjuku-ku, Tokyo, Japan
Eisai Trial Site 155
🇯🇵Suginami-ku, Tokyo, Japan
Eisai Trial Site 156
🇯🇵Suginami-ku, Tokyo, Japan
Eisai Trial Site 82
🇯🇵Yonago-shi, Tottori, Japan
Eisai Trial Site 101
🇯🇵Toyama-shi, Toyama, Japan
Eisai Trial Site 57
🇯🇵Toyama-shi, Toyama, Japan
Eisai Trial Site 139
🇯🇵Tanabe-shi, Wakayama, Japan
Eisai Trial Site 47
🇯🇵Wakayama-shi, Wakayama, Japan
Eisai Trial Site 69
🇯🇵Wakayama-shi, Wakayama, Japan
Eisai Trial Site 121
🇯🇵Matsusaka-shi, Mie, Japan
Eisai Trial Site 35
🇯🇵Matsusaka-shi, Mie, Japan
Eisai Trial Site 238
🇯🇵Toyokawa-shi, Aichi, Japan
Eisai Trial Site 210
🇯🇵Konan-shi, Aichi, Japan
Eisai Trial Site 217
🇯🇵Obu-shi, Aichi, Japan
Eisai Trial Site 234
🇯🇵Asahikawa-shi, Hokkaido, Japan
Eisai Trial Site 209
🇯🇵Kitami-shi, Hokkaido, Japan
Eisai Trial Site 220
🇯🇵Obihiro-shi, Hokkaido, Japan
Eisai Trial Site 223
🇯🇵Akashi-shi, Hyogo, Japan
Eisai Trial Site 207
🇯🇵Kobe-shi, Hyogo, Japan
Eisai Trial Site 230
🇯🇵Tsukuba-shi, Ibaraki, Japan
Eisai Trial Site 218
🇯🇵Kanoya-shi, Kagoshima, Japan
Eisai Trial Site 211
🇯🇵Kumamoto-shi, Kumamoto, Japan
Eisai Trial Site 226
🇯🇵Suzuka-shi, Mie, Japan
Eisai Trial Site 203
🇯🇵Matsumoto-shi, Nagano, Japan
Eisai Trial Site 219
🇯🇵Matsumoto-shi, Nagano, Japan
Eisai Trial Site 222
🇯🇵Omura-shi, Nagasaki, Japan
Eisai Trial Site 225
🇯🇵Joetsu-shi, Niigata, Japan
Eisai Trial Site 215
🇯🇵Okinawa-shi, Okinawa, Japan
Eisai Trial Site 221
🇯🇵Osaka-shi, Osaka, Japan
Eisai Trial Site 224
🇯🇵Osaka-shi, Osaka, Japan
Eisai Trial Site 231
🇯🇵Osaka-shi, Osaka, Japan
Eisai Trial Site 232
🇯🇵Osaka-shi, Osaka, Japan
Eisai Trial Site 241
🇯🇵Osaka-shi, Osaka, Japan
Eisai Trial Site 233
🇯🇵Sakai-shi, Osaka, Japan
Eisai Trial Site 246
🇯🇵Takatsuki-shi, Osaka, Japan
Eisai Trial Site 208
🇯🇵Saitama-shi, Saitama, Japan
Eisai Trial Site 229
🇯🇵Nagahama-shi, Shiga, Japan
Eisai Trial Site 227
🇯🇵Otsu-shi, Shiga, Japan
Eisai Trial Site 235
🇯🇵Iwata-shi, Shizuoka, Japan
Eisai Trial Site 205
🇯🇵Shizuoka-shi, Shizuoka, Japan
Eisai Trial Site 212
🇯🇵Shimotsuke-shi, Tochigi, Japan
Eisai Trial Site 91
🇯🇵Nagoya-shi, Aichi, Japan
Eisai Trial Site 93
🇯🇵Nagoya-shi, Aichi, Japan
Eisai Trial Site 99
🇯🇵Nagoya-shi, Aichi, Japan
Eisai Trial Site 165
🇯🇵Okazaki-shi, Aichi, Japan
Eisai Trial Site 174
🇯🇵Okazaki-shi, Aichi, Japan
Eisai Trial Site 176
🇯🇵Seto-shi, Aichi, Japan
Eisai Trial Site 151
🇯🇵Toyoake-shi, Aichi, Japan
Eisai Trial Site 128
🇯🇵Toyohashi-shi, Aichi, Japan
Eisai Trial Site 131
🇯🇵Toyota-shi, Aichi, Japan
Eisai Trial Site 167
🇯🇵Akita-shi, Akita, Japan
Eisai Trial Site 94
🇯🇵Aomori-shi, Aomori, Japan
Eisai Trial Site 95
🇯🇵Hirosaki-shi, Aomori, Japan
Eisai Trial Site 118
🇯🇵Chiba-shi, Chiba, Japan
Eisai Trial Site 50
🇯🇵Chiba-shi, Chiba, Japan
Eisai Trial Site 79
🇯🇵Chiba-shi, Chiba, Japan
Eisai Trial Site 115
🇯🇵Kamogawa-shi, Chiba, Japan
Eisai Trial Site 4
🇯🇵Kashiwa-shi, Chiba, Japan
Eisai Trial Site 83
🇯🇵Kashiwa-shi, Chiba, Japan
Eisai Trial Site 127
🇯🇵Asahikawa-shi, Hokkaido, Japan
Eisai Trial Site 38
🇯🇵Matsudo-shi, Chiba, Japan
Eisai Trial Site 103
🇯🇵Narita-shi, Chiba, Japan
Eisai Trial Site 109
🇯🇵Urayasu-shi, Chiba, Japan
Eisai Trial Site 24
🇯🇵Matsuyama-shi, Ehime, Japan
Eisai Trial Site 68
🇯🇵Fukui-shi, Fukui, Japan
Eisai Trial Site 66
🇯🇵Yoshida-gun, Fukui, Japan
Eisai Trial Site 14
🇯🇵Fukuoka-shi, Fukuoka, Japan
Eisai Trial Site 186
🇯🇵Yokkaichi-shi, Mie, Japan
Eisai Trial Site 18
🇯🇵Fukuoka-shi, Fukuoka, Japan
Eisai Trial Site 45
🇯🇵Fukuoka-shi, Fukuoka, Japan
Eisai Trial Site 132
🇯🇵Iizuka-shi, Fukuoka, Japan
Eisai Trial Site 110
🇯🇵Hakodate-shi, Hokkaido, Japan
Eisai Trial Site 114
🇯🇵Kitakyushu-shi, Fukuoka, Japan
Eisai Trial Site 119
🇯🇵Kitakyushu-shi, Fukuoka, Japan
Eisai Trial Site 134
🇯🇵Kitakyushu-shi, Fukuoka, Japan
Eisai Trial Site 113
🇯🇵Iwaki-shi, Fukushima, Japan
Eisai Trial Site 81
🇯🇵Iwaki-shi, Fukushima, Japan
Eisai Trial Site 184
🇯🇵Shirakawa-shi, Fukushima, Japan
Eisai Trial Site 26
🇯🇵Gifu-shi, Gifu, Japan
Eisai Trial Site 27
🇯🇵Gifu-shi, Gifu, Japan
Eisai Trial Site 180
🇯🇵Ogaki-shi, Gifu, Japan
Eisai Trial Site 44
🇯🇵Fujioka-shi, Gunma, Japan
Eisai Trial Site 145
🇯🇵Shibukawa-shi, Gunma, Japan
Eisai Trial Site 56
🇯🇵Fukuyama-shi, Hiroshima, Japan
Eisai Trial Site 36
🇯🇵Hiroshima-shi, Hiroshima, Japan
Eisai Trial Site 51
🇯🇵Hiroshima-shi, Hiroshima, Japan
Eisai Trial Site 9
🇯🇵Hiroshima-shi, Hiroshima, Japan
Eisai Trial Site 70
🇯🇵Kushiro-shi, Hokkaido, Japan
Eisai Trial Site 7
🇯🇵Muroran-shi, Hokkaido, Japan
Eisai Trial Site 159
🇯🇵Sapporo-shi, Hokkaido, Japan
Eisai Trial Site 162
🇯🇵Sapporo-shi, Hokkaido, Japan
Eisai Trial Site 173
🇯🇵Kawagoe-shi, Saitama, Japan
Eisai Trial Site 46
🇯🇵Sapporo-shi, Hokkaido, Japan
Eisai Trial Site 71
🇯🇵Akashi-shi, Hyogo, Japan
Eisai Trial Site 30
🇯🇵Amagasaki-shi, Hyogo, Japan
Eisai Trial Site 153
🇯🇵Izumi-shi, Osaka, Japan
Eisai Trial Site 123
🇯🇵Itami-shi, Hyogo, Japan
Eisai Trial Site 84
🇯🇵Kobe-shi, Hyogo, Japan
Eisai Trial Site 88
🇯🇵Kobe-shi, Hyogo, Japan
Eisai Trial Site 92
🇯🇵Kobe-shi, Hyogo, Japan
Eisai Trial Site 43
🇯🇵Nishinomiya-shi, Hyogo, Japan
Eisai Trial Site 28
🇯🇵Hitachi-shi, Ibaraki, Japan
Eisai Trial Site 148
🇯🇵Saitama-shi, Saitama, Japan
Eisai Trial Site 142
🇯🇵Tsuchiura-shi, Ibaraki, Japan
Eisai Trial Site 10
🇯🇵Tsukuba-shi, Ibaraki, Japan
Eisai Trial Site 166
🇯🇵Kanazawa-shi, Ishikawa, Japan
Eisai Trial Site 37
🇯🇵Kanazawa-shi, Ishikawa, Japan
Eisai Trial Site 116
🇯🇵Kita-gun, Kagawa, Japan
Eisai Trial Site 85
🇯🇵Sakaide-shi, Kagawa, Japan
Eisai Trial Site 104
🇯🇵Takamatsu-shi, Kagawa, Japan
Eisai Trial Site 111
🇯🇵Takamatsu-shi, Kagawa, Japan
Eisai Trial Site 117
🇯🇵Kagoshima-shi, Kagoshima, Japan
Eisai Trial Site 33
🇯🇵Kagoshima-shi, Kagoshima, Japan
Eisai Trial Site 108
🇯🇵Ebina-shi, Kanagawa, Japan
Eisai Trial Site 150
🇯🇵Kamakura-shi, Kanagawa, Japan
Eisai Trial Site 137
🇯🇵Kawasaki-shi, Kanagawa, Japan
Eisai Trial Site 16
🇯🇵Kawasaki-shi, Kanagawa, Japan
Eisai Trial Site 181
🇯🇵Kawasaki-shi, Kanagawa, Japan
Eisai Trial Site 86
🇯🇵Sagamihara-shi, Kanagawa, Japan
Eisai Trial Site 124
🇯🇵Yokohama-shi, Kanagawa, Japan
Eisai Trial Site 169
🇯🇵Yokohama-shi, Kanagawa, Japan
Eisai Trial Site 42
🇯🇵Yokohama-shi, Kanagawa, Japan
Eisai Trial Site 6
🇯🇵Yokohama-shi, Kanagawa, Japan
Eisai Trial Site 76
🇯🇵Yokohama-shi, Kanagawa, Japan
Eisai Trial Site 164
🇯🇵Yokosuka-shi, Kanagawa, Japan
Eisai Trial Site 8
🇯🇵Nankoku-shi, Kochi, Japan
Eisai Trial Site 175
🇯🇵Kumamoto-shi, Kumamoto, Japan
Eisai Trial Site 54
🇯🇵Kumamoto-shi, Kumamoto, Japan
Eisai Trial Site 67
🇯🇵Kumamoto-shi, Kumamoto, Japan
Eisai Trial Site 53
🇯🇵Fukuchiyama-shi, Kyoto, Japan
Eisai Trial Site 12
🇯🇵Kyoto-shi, Kyoto, Japan
Eisai Trial Site 133
🇯🇵Kyoto-shi, Kyoto, Japan
Eisai Trial Site 25
🇯🇵Kyoto-shi, Kyoto, Japan
Eisai Trial Site 3
🇯🇵Kyoto-shi, Kyoto, Japan
Eisai Trial Site 55
🇯🇵Kyoto-shi, Kyoto, Japan
Eisai Trial Site 75
🇯🇵Kyoto-shi, Kyoto, Japan
Eisai Trial Site 98
🇯🇵Iga-shi, Mie, Japan
Eisai Trial Site 31
🇯🇵Ise-shi, Mie, Japan
Eisai Trial Site 107
🇯🇵Suzuka-shi, Mie, Japan
Eisai Trial Site 63
🇯🇵Natori-shi, Miyagi, Japan
Eisai Trial Site 157
🇯🇵Sendai-shi, Miyagi, Japan
Eisai Trial Site 73
🇯🇵Sendai-shi, Miyagi, Japan
Eisai Trial Site 179
🇯🇵Nobeoka-shi, Miyazaki, Japan
Eisai Trial Site 61
🇯🇵Nagano-shi, Nagano, Japan
Eisai Trial Site 125
🇯🇵Nagasaki-shi, Nagasaki, Japan
Eisai Trial Site 136
🇯🇵Tenri-shi, Nara, Japan
Eisai Trial Site 5
🇯🇵Kurashiki-shi, Okayama, Japan
Eisai Trial Site 2
🇯🇵Maniwa-shi, Okayama, Japan
Eisai Trial Site 11
🇯🇵Okayama-shi, Okayama, Japan
Eisai Trial Site 40
🇯🇵Okayama-shi, Okayama, Japan
Eisai Trial Site 41
🇯🇵Okayama-shi, Okayama, Japan
Eisai Trial Site 17
🇯🇵Nakagami-gun, Okinawa, Japan
Eisai Trial Site 96
🇯🇵Uruma-shi, Okinawa, Japan
Eisai Trial Site 160
🇯🇵Hirakata-shi, Osaka, Japan
Eisai Trial Site 48
🇯🇵Izumisano-shi, Osaka, Japan
Eisai Trial Site 58
🇯🇵Kawachinagano-shi, Osaka, Japan
Eisai Trial Site 65
🇯🇵Moriguchi-shi, Osaka, Japan
Eisai Trial Site 112
🇯🇵Osaka-shi, Osaka, Japan
Eisai Trial Site 122
🇯🇵Osaka-shi, Osaka, Japan
Eisai Trial Site 141
🇯🇵Osaka-shi, Osaka, Japan
Eisai Trial Site 147
🇯🇵Osaka-shi, Osaka, Japan
Eisai Trial Site 161
🇯🇵Osaka-shi, Osaka, Japan
Eisai Trial Site 171
🇯🇵Osaka-shi, Osaka, Japan
Eisai Trial Site 183
🇯🇵Osaka-shi, Osaka, Japan
Eisai Trial Site 29
🇯🇵Osaka-shi, Osaka, Japan
Eisai Trial Site 52
🇯🇵Osaka-shi, Osaka, Japan
Eisai Trial Site 59
🇯🇵Osaka-shi, Osaka, Japan
Eisai Trial Site 21
🇯🇵Osakasayama-shi, Osaka, Japan
Eisai Trial Site 130
🇯🇵Suita-shi, Osaka, Japan
Eisai Trial Site 60
🇯🇵Takatsuki-shi, Osaka, Japan
Eisai Trial Site 97
🇯🇵Toyonaka-shi, Osaka, Japan
Eisai Trial Site 144
🇯🇵Hidaka-shi, Saitama, Japan
Eisai Trial Site 140
🇯🇵Iruma-gun, Saitama, Japan
Eisai Trial Site 74
🇯🇵Koshigaya-shi, Saitama, Japan
Eisai Trial Site 138
🇯🇵Tokorozawa-shi, Saitama, Japan
Eisai Trial Site 177
🇯🇵Otsu-shi, Shiga, Japan
Eisai Trial Site 102
🇯🇵Ritto-shi, Shiga, Japan
Eisai Trial Site 39
🇯🇵Izunokuni-shi, Shizuoka, Japan
Eisai Trial Site 143
🇯🇵Shimada-shi, Shizuoka, Japan
Eisai Trial Site 87
🇯🇵Shizuoka-shi, Shizuoka, Japan
Eisai Trial Site 22
🇯🇵Sunto-gun, Shizuoka, Japan
Eisai Trial Site 34
🇯🇵Shimotsuga-gun, Tochigi, Japan
Eisai Trial Site 100
🇯🇵Tokushima-shi, Tokushima, Japan
Eisai Trial Site 182
🇯🇵Tokushima-shi, Tokushima, Japan
Eisai Trial Site 64
🇯🇵Tokushima-shi, Tokushima, Japan
Eisai Trial Site 154
🇯🇵Bunkyo-ku, Tokyo, Japan
Eisai Trial Site 72
🇯🇵Bunkyo-ku, Tokyo, Japan
Eisai Trial Site 77
🇯🇵Bunkyo-ku, Tokyo, Japan
Eisai Trial Site 1
🇯🇵Chuo-ku, Tokyo, Japan
Eisai Trial Site 106
🇯🇵Edogawa-ku, Tokyo, Japan
Eisai Trial Site 78
🇯🇵Itabashi-ku, Tokyo, Japan
Eisai Trial Site 120
🇯🇵Komae-shi, Tokyo, Japan
Eisai Trial Site 32
🇯🇵Koto-ku, Tokyo, Japan
Eisai Trial Site 146
🇯🇵Minato-ku, Tokyo, Japan
Eisai Trial Site 15
🇯🇵Minato-ku, Tokyo, Japan
Eisai Trial Site 49
🇯🇵Minato-ku, Tokyo, Japan
Eisai Trial Site 135
🇯🇵Ome-shi, Tokyo, Japan
Eisai Trial Site 149
🇯🇵Shinagawa-Ku, Tokyo, Japan
Eisai Trial Site 23
🇯🇵Shinagawa-Ku, Tokyo, Japan
Eisai Trial Site 19
🇯🇵Sakata-shi, Yamagata, Japan
Eisai Trial Site 62
🇯🇵Yamagata-shi, Yamagata, Japan