Lymphoma, Follicular Clinical Trial
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
| Verified date | December 2023 |
| Source | Eisai Inc. |
| Contact | Inquiry Service |
| eisai-chiken_hotline[@]hhc.eisai.co.jp | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 145 |
| Est. completion date | March 31, 2028 |
| Est. primary completion date | March 31, 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Eisai Trial Site 71 | Akashi-shi | Hyogo |
| Japan | Eisai Trial Site 167 | Akita-shi | Akita |
| Japan | Eisai Trial Site 30 | Amagasaki-shi | Hyogo |
| Japan | Eisai Trial Site 172 | Anjo-shi | Aichi |
| Japan | Eisai Trial Site 94 | Aomori-shi | Aomori |
| Japan | Eisai Trial Site 127 | Asahikawa-shi | Hokkaido |
| 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 118 | Chiba-shi | Chiba |
| Japan | Eisai Trial Site 50 | Chiba-shi | Chiba |
| Japan | Eisai Trial Site 79 | Chiba-shi | Chiba |
| Japan | Eisai Trial Site 1 | Chuo-ku | Tokyo |
| Japan | Eisai Trial Site 108 | Ebina-shi | Kanagawa |
| Japan | Eisai Trial Site 106 | Edogawa-ku | Tokyo |
| Japan | Eisai Trial Site 44 | Fujioka-shi | Gunma |
| Japan | Eisai Trial Site 53 | Fukuchiyama-shi | Kyoto |
| Japan | Eisai Trial Site 68 | Fukui-shi | Fukui |
| Japan | Eisai Trial Site 14 | Fukuoka-shi | Fukuoka |
| Japan | Eisai Trial Site 18 | Fukuoka-shi | Fukuoka |
| Japan | Eisai Trial Site 45 | Fukuoka-shi | Fukuoka |
| Japan | Eisai Trial Site 56 | Fukuyama-shi | Hiroshima |
| Japan | Eisai Trial Site 26 | Gifu-shi | Gifu |
| Japan | Eisai Trial Site 27 | Gifu-shi | Gifu |
| Japan | Eisai Trial Site 110 | Hakodate-shi | Hokkaido |
| Japan | Eisai Trial Site 144 | Hidaka-shi | Saitama |
| Japan | Eisai Trial Site 153 | Himeji-shi | Hyogo |
| Japan | Eisai Trial Site 160 | Hirakata-shi | Osaka |
| Japan | Eisai Trial Site 95 | Hirosaki-shi | Aomori |
| 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 28 | Hitachi-shi | Ibaraki |
| Japan | Eisai Trial Site 98 | Iga-shi | Mie |
| Japan | Eisai Trial Site 132 | Iizuka-shi | Fukuoka |
| Japan | Eisai Trial Site 140 | Iruma-gun | Saitama |
| Japan | Eisai Trial Site 31 | Ise-shi | Mie |
| Japan | Eisai Trial Site 78 | Itabashi-ku | Tokyo |
| Japan | Eisai Trial Site 123 | Itami-shi | Hyogo |
| Japan | Eisai Trial Site 113 | Iwaki-shi | Fukushima |
| Japan | Eisai Trial Site 81 | Iwaki-shi | Fukushima |
| Japan | Eisai Trial Site 178 | Izumi-shi | Osaka |
| Japan | Eisai Trial Site 48 | Izumisano-shi | Osaka |
| Japan | Eisai Trial Site 39 | Izunokuni-shi | Shizuoka |
| Japan | Eisai Trial Site 117 | Kagoshima-shi | Kagoshima |
| Japan | Eisai Trial Site 33 | Kagoshima-shi | Kagoshima |
| Japan | Eisai Trial Site 150 | Kamakura-shi | Kanagawa |
| Japan | Eisai Trial Site 115 | Kamogawa-shi | Chiba |
| Japan | Eisai Trial Site 166 | Kanazawa-shi | Ishikawa |
| Japan | Eisai Trial Site 37 | Kanazawa-shi | Ishikawa |
| Japan | Eisai Trial Site 4 | Kashiwa-shi | Chiba |
| Japan | Eisai Trial Site 83 | Kashiwa-shi | Chiba |
| Japan | Eisai Trial Site 58 | Kawachinagano-shi | Osaka |
| 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 116 | Kita-gun | Kagawa |
| 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 84 | Kobe-shi | Hyogo |
| Japan | Eisai Trial Site 88 | Kobe-shi | Hyogo |
| Japan | Eisai Trial Site 92 | Kobe-shi | Hyogo |
| Japan | Eisai Trial Site 120 | Komae-shi | Tokyo |
| Japan | Eisai Trial Site 129 | Komaki-shi | Aichi |
| Japan | Eisai Trial Site 74 | Koshigaya-shi | Saitama |
| Japan | Eisai Trial Site 32 | Koto-ku | Tokyo |
| 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 5 | Kurashiki-shi | Okayama |
| Japan | Eisai Trial Site 70 | Kushiro-shi | Hokkaido |
| 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 2 | Maniwa-shi | Okayama |
| Japan | Eisai Trial Site 38 | Matsudo-shi | Chiba |
| Japan | Eisai Trial Site 121 | Matsusaka-shi | Mie |
| Japan | Eisai Trial Site 35 | Matsusaka-shi | Mie |
| Japan | Eisai Trial Site 24 | Matsuyama-shi | Ehime |
| 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 126 | Mitaka-shi | Tokyo |
| Japan | Eisai Trial Site 185 | Mito-shi | Ibaraki |
| Japan | Eisai Trial Site 65 | Moriguchi-shi | Osaka |
| Japan | Eisai Trial Site 7 | Muroran-shi | Hokkaido |
| Japan | Eisai Trial Site 89 | Musashino-shi | Tokyo |
| Japan | Eisai Trial Site 20 | Nagakute-shi | Aichi |
| Japan | Eisai Trial Site 61 | Nagano-shi | Nagano |
| Japan | Eisai Trial Site 125 | Nagasaki-shi | Nagasaki |
| 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 91 | Nagoya-shi | Aichi |
| Japan | Eisai Trial Site 93 | Nagoya-shi | Aichi |
| Japan | Eisai Trial Site 99 | Nagoya-shi | Aichi |
| Japan | Eisai Trial Site 17 | Nakagami-gun | Okinawa |
| Japan | Eisai Trial Site 8 | Nankoku-shi | Kochi |
| Japan | Eisai Trial Site 103 | Narita-shi | Chiba |
| Japan | Eisai Trial Site 63 | Natori-shi | Miyagi |
| Japan | Eisai Trial Site 43 | Nishinomiya-shi | Hyogo |
| Japan | Eisai Trial Site 179 | Nobeoka-shi | Miyazaki |
| Japan | Eisai Trial Site 180 | Ogaki-shi | Gifu |
| Japan | Eisai Trial Site 11 | Okayama-shi | Okayama |
| Japan | Eisai Trial Site 13 | Okayama-shi | Okayama |
| Japan | Eisai Trial Site 170 | Okayama-shi | Okayama |
| Japan | Eisai Trial Site 40 | Okayama-shi | Okayama |
| Japan | Eisai Trial Site 41 | Okayama-shi | Okayama |
| Japan | Eisai Trial Site 165 | Okazaki-shi | Aichi |
| Japan | Eisai Trial Site 174 | Okazaki-shi | Aichi |
| Japan | Eisai Trial Site 135 | Ome-shi | Tokyo |
| 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 177 | Otsu-shi | Shiga |
| Japan | Eisai Trial Site 102 | Ritto-shi | Shiga |
| Japan | Eisai Trial Site 86 | Sagamihara-shi | Kanagawa |
| Japan | Eisai Trial Site 148 | Saitama-shi | Saitama |
| Japan | Eisai Trial Site 85 | Sakaide-shi | Kagawa |
| Japan | Eisai Trial Site 19 | Sakata-shi | Yamagata |
| Japan | Eisai Trial Site 159 | Sapporo-shi | Hokkaido |
| Japan | Eisai Trial Site 162 | Sapporo-shi | Hokkaido |
| Japan | Eisai Trial Site 173 | Sapporo-shi | Hokkaido |
| Japan | Eisai Trial Site 46 | Sapporo-shi | Hokkaido |
| Japan | Eisai Trial Site 157 | Sendai-shi | Miyagi |
| Japan | Eisai Trial Site 73 | Sendai-shi | Miyagi |
| Japan | Eisai Trial Site 176 | Seto-shi | Aichi |
| Japan | Eisai Trial Site 145 | Shibukawa-shi | Gunma |
| Japan | Eisai Trial Site 143 | Shimada-shi | Shizuoka |
| Japan | Eisai Trial Site 34 | Shimotsuga-gun | Tochigi |
| Japan | Eisai Trial Site 149 | Shinagawa-Ku | Tokyo |
| Japan | Eisai Trial Site 23 | Shinagawa-Ku | Tokyo |
| Japan | Eisai Trial Site 158 | Shinjuku-ku | Tokyo |
| Japan | Eisai Trial Site 80 | Shinjuku-ku | Tokyo |
| Japan | Eisai Trial Site 184 | Shirakawa-shi | Fukushima |
| Japan | Eisai Trial Site 87 | Shizuoka-shi | Shizuoka |
| Japan | Eisai Trial Site 155 | Suginami-ku | Tokyo |
| Japan | Eisai Trial Site 156 | Suginami-ku | Tokyo |
| Japan | Eisai Trial Site 130 | Suita-shi | Osaka |
| Japan | Eisai Trial Site 22 | Sunto-gun | Shizuoka |
| Japan | Eisai Trial Site 107 | Suzuka-shi | Mie |
| Japan | Eisai Trial Site 104 | Takamatsu-shi | Kagawa |
| Japan | Eisai Trial Site 111 | Takamatsu-shi | Kagawa |
| Japan | Eisai Trial Site 60 | Takatsuki-shi | Osaka |
| Japan | Eisai Trial Site 139 | Tanabe-shi | Wakayama |
| Japan | Eisai Trial Site 136 | Tenri-shi | Nara |
| Japan | Eisai Trial Site 138 | Tokorozawa-shi | Saitama |
| 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 101 | Toyama-shi | Toyama |
| Japan | Eisai Trial Site 57 | Toyama-shi | Toyama |
| Japan | Eisai Trial Site 151 | Toyoake-shi | Aichi |
| Japan | Eisai Trial Site 128 | Toyohashi-shi | Aichi |
| Japan | Eisai Trial Site 97 | Toyonaka-shi | Osaka |
| Japan | Eisai Trial Site 131 | Toyota-shi | Aichi |
| Japan | Eisai Trial Site 142 | Tsuchiura-shi | Ibaraki |
| Japan | Eisai Trial Site 10 | Tsukuba-shi | Ibaraki |
| Japan | Eisai Trial Site 109 | Urayasu-shi | Chiba |
| Japan | Eisai Trial Site 96 | Uruma-shi | Okinawa |
| Japan | Eisai Trial Site 47 | Wakayama-shi | Wakayama |
| Japan | Eisai Trial Site 69 | Wakayama-shi | Wakayama |
| Japan | Eisai Trial Site 62 | Yamagata-shi | Yamagata |
| Japan | Eisai Trial Site 186 | Yokkaichi-shi | Mie |
| 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 82 | Yonago-shi | Tottori |
| Japan | Eisai Trial Site 66 | Yoshida-gun | Fukui |
| Lead Sponsor | Collaborator |
|---|---|
| Eisai Co., Ltd. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | 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. | Up to Week 52 | |
| Secondary | 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. | Up to Week 52 |
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