Investigating the safety of tazemetostat for patients with specific lymphoma in Japan
A Post-marketing Observational Study of Tazemetostat on Safety in Patients With Relapsed or Refractory Follicular Lymphoma With EZH2 Gene Mutation in Japan
This study is testing the safety of a drug called tazemetostat in patients with a specific type of lymphoma that has an EZH2 gene mutation to see how it works in real-life situations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 145 (estimated) |
| Sex | All |
| Sponsor | Eisai Inc. Industry-sponsored |
| Locations | 232 sites (Anjo-shi, Aichi and 231 other locations) |
| Trial ID | NCT05228158 on ClinicalTrials.gov |
What this trial studies
This study focuses on assessing the safety of tazemetostat in patients who have relapsed or refractory follicular lymphoma with an EZH2 gene mutation. It is conducted in a real-world clinical setting, allowing for the observation of the drug's effects under daily practice conditions. Participants will be those who have already been treated with tazemetostat, providing insights into its safety profile in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with relapsed or refractory follicular lymphoma who have an EZH2 gene mutation and have previously been treated with tazemetostat.
Not a fit: Patients who have a history of hypersensitivity to any ingredient of Tazverik will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the safety of tazemetostat, potentially leading to improved treatment options for patients with this type of lymphoma.
How similar studies have performed: While this study is focused on safety, similar studies investigating tazemetostat have shown promising results in treating patients with EZH2 mutations, indicating a potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Anjo-shi, Aichi and 231 other locations
- Eisai Trial Site 172 — Anjo-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 129 — Komaki-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 210 — Konan-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 20 — Nagakute-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 105 — Nagoya-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 152 — Nagoya-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 163 — Nagoya-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 168 — Nagoya-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 90 — Nagoya-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 91 — Nagoya-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 93 — Nagoya-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 99 — Nagoya-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 217 — Obu-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 165 — Okazaki-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 174 — Okazaki-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 176 — Seto-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 151 — Toyoake-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 128 — Toyohashi-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 238 — Toyokawa-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 131 — Toyota-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 216 — Yatomi-shi, Aichi, Japan (Recruiting)
- Eisai Trial Site 167 — Akita-shi, Akita, Japan (Recruiting)
- Eisai Trial Site 94 — Aomori-shi, Aomori, Japan (Recruiting)
- Eisai Trial Site 95 — Hirosaki-shi, Aomori, Japan (Recruiting)
- Eisai Trial Site 118 — Chiba-shi, Chiba, Japan (Recruiting)
- Eisai Trial Site 50 — Chiba-shi, Chiba, Japan (Recruiting)
- Eisai Trial Site 79 — Chiba-shi, Chiba, Japan (Recruiting)
- Eisai Trial Site 115 — Kamogawa-shi, Chiba, Japan (Recruiting)
- Eisai Trial Site 4 — Kashiwa-shi, Chiba, Japan (Recruiting)
- Eisai Trial Site 83 — Kashiwa-shi, Chiba, Japan (Recruiting)
- Eisai Trial Site 206 — Matsudo-shi, Chiba, Japan (Recruiting)
- Eisai Trial Site 38 — Matsudo-shi, Chiba, Japan (Recruiting)
- Eisai Trial Site 103 — Narita-shi, Chiba, Japan (Recruiting)
- Eisai Trial Site 109 — Urayasu-shi, Chiba, Japan (Recruiting)
- Eisai Trial Site 24 — Matsuyama-shi, Ehime, Japan (Recruiting)
- Eisai Trial Site 68 — Fukui-shi, Fukui, Japan (Recruiting)
- Eisai Trial Site 66 — Yoshida-gun, Fukui, Japan (Recruiting)
- Eisai Trial Site 14 — Fukuoka-shi, Fukuoka, Japan (Recruiting)
- Eisai Trial Site 186 — Fukuoka-shi, Fukuoka, Japan (Recruiting)
- Eisai Trial Site 18 — Fukuoka-shi, Fukuoka, Japan (Recruiting)
- Eisai Trial Site 240 — Fukuoka-shi, Fukuoka, Japan (Recruiting)
- Eisai Trial Site 45 — Fukuoka-shi, Fukuoka, Japan (Recruiting)
- Eisai Trial Site 132 — Iizuka-shi, Fukuoka, Japan (Recruiting)
- Eisai Trial Site 114 — Kitakyushu-shi, Fukuoka, Japan (Recruiting)
- Eisai Trial Site 119 — Kitakyushu-shi, Fukuoka, Japan (Recruiting)
- Eisai Trial Site 134 — Kitakyushu-shi, Fukuoka, Japan (Recruiting)
- Eisai Trial Site 243 — Kitakyusyu-shi, Fukuoka, Japan (Recruiting)
- Eisai Trial Site 245 — Kurume-shi, Fukuoka, Japan (Recruiting)
- Eisai Trial Site 113 — Iwaki-shi, Fukushima, Japan (Recruiting)
- Eisai Trial Site 81 — Iwaki-shi, Fukushima, Japan (Recruiting)
+182 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Inquiry Service
- Email: eisai-chiken_hotline@hhc.eisai.co.jp
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.