Clinical trial NCT05228158: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma, Follicular
Keywords: E7438
Tazemetostat
Tazverik
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-08
Enrollment: 145
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with relapsed or refractory follicular lymphoma with EZH2 gene mutation will be enrolled in this study.

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.


Eligibility criteria: 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

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