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

December 15, 2023 updated by: Eisai Co., Ltd.

A Post-marketing Observational Study of Tazemetostat on Safety in Patients With Relapsed or Refractory Follicular Lymphoma With EZH2 Gene Mutation in Japan

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.

Study Overview

Status

Recruiting

Conditions

Lymphoma, Follicular

Intervention / Treatment

Drug: Tazemetostat

Study Type

Observational

Enrollment (Estimated)

145

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Inquiry Service
Email: eisai-chiken_hotline@hhc.eisai.co.jp

Study Locations

Japan
- Aichi
  - Anjo-shi, Aichi, Japan
    - Recruiting
    - Eisai Trial Site 172
  - Komaki-shi, Aichi, Japan
    - Recruiting
    - Eisai Trial Site 129
  - Nagakute-shi, Aichi, Japan
    - Recruiting
    - Eisai Trial Site 20
  - Nagoya-shi, Aichi, Japan
    - Recruiting
    - Eisai Trial Site 163
  - Nagoya-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 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
  - Okazaki-shi, Aichi, Japan
    - Recruiting
    - Eisai Trial Site 165
  - Okazaki-shi, Aichi, Japan
    - Recruiting
    - Eisai Trial Site 174
  - Seto-shi, Aichi, Japan
    - Recruiting
    - Eisai Trial Site 176
  - Toyoake-shi, Aichi, Japan
    - Recruiting
    - Eisai Trial Site 151
  - Toyohashi-shi, Aichi, Japan
    - Recruiting
    - Eisai Trial Site 128
  - Toyota-shi, Aichi, Japan
    - Recruiting
    - Eisai Trial Site 131
- Akita
  - Akita-shi, Akita, Japan
    - Recruiting
    - Eisai Trial Site 167
- Aomori
  - Aomori-shi, Aomori, Japan
    - Recruiting
    - Eisai Trial Site 94
  - Hirosaki-shi, Aomori, Japan
    - Recruiting
    - Eisai Trial Site 95
- Chiba
  - Chiba-shi, Chiba, Japan
    - Recruiting
    - Eisai Trial Site 118
  - Chiba-shi, Chiba, Japan
    - Recruiting
    - Eisai Trial Site 50
  - Chiba-shi, Chiba, Japan
    - Recruiting
    - Eisai Trial Site 79
  - Kamogawa-shi, Chiba, Japan
    - Recruiting
    - Eisai Trial Site 115
  - Kashiwa-shi, Chiba, Japan
    - Recruiting
    - Eisai Trial Site 4
  - Kashiwa-shi, Chiba, Japan
    - Recruiting
    - Eisai Trial Site 83
  - Matsudo-shi, Chiba, Japan
    - Recruiting
    - Eisai Trial Site 38
  - Narita-shi, Chiba, Japan
    - Recruiting
    - Eisai Trial Site 103
  - Urayasu-shi, Chiba, Japan
    - Recruiting
    - Eisai Trial Site 109
- Ehime
  - Matsuyama-shi, Ehime, Japan
    - Recruiting
    - Eisai Trial Site 24
- Fukui
  - Fukui-shi, Fukui, Japan
    - Recruiting
    - Eisai Trial Site 68
  - Yoshida-gun, Fukui, Japan
    - Recruiting
    - Eisai Trial Site 66
- Fukuoka
  - Fukuoka-shi, Fukuoka, Japan
    - Recruiting
    - Eisai Trial Site 14
  - Fukuoka-shi, Fukuoka, Japan
    - Recruiting
    - Eisai Trial Site 18
  - Fukuoka-shi, Fukuoka, Japan
    - Recruiting
    - Eisai Trial Site 45
  - Iizuka-shi, Fukuoka, Japan
    - Recruiting
    - Eisai Trial Site 132
  - Kitakyushu-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
- Fukushima
  - Iwaki-shi, Fukushima, Japan
    - Recruiting
    - Eisai Trial Site 113
  - Iwaki-shi, Fukushima, Japan
    - Recruiting
    - Eisai Trial Site 81
  - Shirakawa-shi, Fukushima, Japan
    - Recruiting
    - Eisai Trial Site 184
- Gifu
  - Gifu-shi, Gifu, Japan
    - Recruiting
    - Eisai Trial Site 27
  - Gifu-shi, Gifu, Japan
    - Recruiting
    - Eisai Trial Site 26
  - Ogaki-shi, Gifu, Japan
    - Recruiting
    - Eisai Trial Site 180
- Gunma
  - Fujioka-shi, Gunma, Japan
    - Recruiting
    - Eisai Trial Site 44
  - Shibukawa-shi, Gunma, Japan
    - Recruiting
    - Eisai Trial Site 145
- Hiroshima
  - Fukuyama-shi, Hiroshima, Japan
    - Recruiting
    - Eisai Trial Site 56
  - Hiroshima-shi, Hiroshima, Japan
    - Recruiting
    - Eisai Trial Site 36
  - Hiroshima-shi, Hiroshima, Japan
    - Recruiting
    - Eisai Trial Site 51
  - Hiroshima-shi, Hiroshima, Japan
    - Recruiting
    - Eisai Trial Site 9
- Hokkaido
  - Asahikawa-shi, Hokkaido, Japan
    - Recruiting
    - Eisai Trial Site 127
  - Hakodate-shi, Hokkaido, Japan
    - Recruiting
    - Eisai Trial Site 110
  - Kushiro-shi, Hokkaido, Japan
    - Recruiting
    - Eisai Trial Site 70
  - Muroran-shi, Hokkaido, Japan
    - Recruiting
    - Eisai Trial Site 7
  - Sapporo-shi, Hokkaido, Japan
    - Recruiting
    - Eisai Trial Site 159
  - Sapporo-shi, Hokkaido, Japan
    - Recruiting
    - Eisai Trial Site 162
  - Sapporo-shi, Hokkaido, Japan
    - Recruiting
    - Eisai Trial Site 173
  - Sapporo-shi, Hokkaido, Japan
    - Recruiting
    - Eisai Trial Site 46
- Hyogo
  - Akashi-shi, Hyogo, Japan
    - Recruiting
    - Eisai Trial Site 71
  - Amagasaki-shi, Hyogo, Japan
    - Recruiting
    - Eisai Trial Site 30
  - Himeji-shi, Hyogo, Japan
    - Recruiting
    - Eisai Trial Site 153
  - Itami-shi, Hyogo, Japan
    - Recruiting
    - Eisai Trial Site 123
  - Kobe-shi, Hyogo, Japan
    - Recruiting
    - Eisai Trial Site 84
  - Kobe-shi, Hyogo, Japan
    - Recruiting
    - Eisai Trial Site 88
  - Kobe-shi, Hyogo, Japan
    - Recruiting
    - Eisai Trial Site 92
  - Nishinomiya-shi, Hyogo, Japan
    - Recruiting
    - Eisai Trial Site 43
- Ibaraki
  - Hitachi-shi, Ibaraki, Japan
    - Recruiting
    - Eisai Trial Site 28
  - Mito-shi, Ibaraki, Japan
    - Recruiting
    - Eisai Trial Site 185
  - Tsuchiura-shi, Ibaraki, Japan
    - Recruiting
    - Eisai Trial Site 142
  - Tsukuba-shi, Ibaraki, Japan
    - Recruiting
    - Eisai Trial Site 10
- Ishikawa
  - Kanazawa-shi, Ishikawa, Japan
    - Recruiting
    - Eisai Trial Site 166
  - Kanazawa-shi, Ishikawa, Japan
    - Recruiting
    - Eisai Trial Site 37
- Kagawa
  - Kita-gun, Kagawa, Japan
    - Recruiting
    - Eisai Trial Site 116
  - Sakaide-shi, Kagawa, Japan
    - Recruiting
    - Eisai Trial Site 85
  - Takamatsu-shi, Kagawa, Japan
    - Recruiting
    - Eisai Trial Site 104
  - Takamatsu-shi, Kagawa, Japan
    - Recruiting
    - Eisai Trial Site 111
- Kagoshima
  - Kagoshima-shi, Kagoshima, Japan
    - Recruiting
    - Eisai Trial Site 117
  - Kagoshima-shi, Kagoshima, Japan
    - Recruiting
    - Eisai Trial Site 33
- Kanagawa
  - Ebina-shi, Kanagawa, Japan
    - Recruiting
    - Eisai Trial Site 108
  - Kamakura-shi, Kanagawa, Japan
    - Recruiting
    - Eisai Trial Site 150
  - Kawasaki-shi, Kanagawa, Japan
    - Recruiting
    - Eisai Trial Site 137
  - Kawasaki-shi, Kanagawa, Japan
    - Recruiting
    - Eisai Trial Site 16
  - Kawasaki-shi, Kanagawa, Japan
    - Recruiting
    - Eisai Trial Site 181
  - Sagamihara-shi, Kanagawa, Japan
    - Recruiting
    - Eisai Trial Site 86
  - Yokohama-shi, Kanagawa, Japan
    - Recruiting
    - Eisai Trial Site 124
  - Yokohama-shi, Kanagawa, Japan
    - Recruiting
    - Eisai Trial Site 169
  - Yokohama-shi, Kanagawa, Japan
    - Recruiting
    - Eisai Trial Site 42
  - Yokohama-shi, Kanagawa, Japan
    - Recruiting
    - Eisai Trial Site 6
  - Yokohama-shi, Kanagawa, Japan
    - Recruiting
    - Eisai Trial Site 76
  - Yokosuka-shi, Kanagawa, Japan
    - Recruiting
    - Eisai Trial Site 164
- Kochi
  - Nankoku-shi, Kochi, Japan
    - Recruiting
    - Eisai Trial Site 8
- Kumamoto
  - Kumamoto-shi, Kumamoto, Japan
    - Recruiting
    - Eisai Trial Site 175
  - Kumamoto-shi, Kumamoto, Japan
    - Recruiting
    - Eisai Trial Site 54
  - Kumamoto-shi, Kumamoto, Japan
    - Recruiting
    - Eisai Trial Site 67
- Kyoto
  - Fukuchiyama-shi, Kyoto, Japan
    - Recruiting
    - Eisai Trial Site 53
  - Kyoto-shi, Kyoto, Japan
    - Recruiting
    - Eisai Trial Site 12
  - Kyoto-shi, Kyoto, Japan
    - Recruiting
    - Eisai Trial Site 133
  - Kyoto-shi, Kyoto, Japan
    - Recruiting
    - Eisai Trial Site 25
  - Kyoto-shi, Kyoto, Japan
    - Recruiting
    - Eisai Trial Site 3
  - Kyoto-shi, Kyoto, Japan
    - Recruiting
    - Eisai Trial Site 55
  - Kyoto-shi, Kyoto, Japan
    - Recruiting
    - Eisai Trial Site 75
- Mie
  - Iga-shi, Mie, Japan
    - Recruiting
    - Eisai Trial Site 98
  - Ise-shi, Mie, Japan
    - Recruiting
    - Eisai Trial Site 31
  - Matsusaka-shi, Mie, Japan
    - Recruiting
    - Eisai Trial Site 121
  - Matsusaka-shi, Mie, Japan
    - Recruiting
    - Eisai Trial Site 35
  - Suzuka-shi, Mie, Japan
    - Recruiting
    - Eisai Trial Site 107
  - Yokkaichi-shi, Mie, Japan
    - Recruiting
    - Eisai Trial Site 186
- Miyagi
  - Natori-shi, Miyagi, Japan
    - Recruiting
    - Eisai Trial Site 63
  - Sendai-shi, Miyagi, Japan
    - Recruiting
    - Eisai Trial Site 157
  - Sendai-shi, Miyagi, Japan
    - Recruiting
    - Eisai Trial Site 73
- Miyazaki
  - Nobeoka-shi, Miyazaki, Japan
    - Recruiting
    - Eisai Trial Site 179
- Nagano
  - Nagano-shi, Nagano, Japan
    - Recruiting
    - Eisai Trial Site 61
- Nagasaki
  - Nagasaki-shi, Nagasaki, Japan
    - Recruiting
    - Eisai Trial Site 125
- Nara
  - Tenri-shi, Nara, Japan
    - Recruiting
    - Eisai Trial Site 136
- Okayama
  - Kurashiki-shi, Okayama, Japan
    - Recruiting
    - Eisai Trial Site 5
  - Maniwa-shi, Okayama, Japan
    - Recruiting
    - Eisai Trial Site 2
  - Okayama-shi, Okayama, Japan
    - Recruiting
    - Eisai Trial Site 41
  - Okayama-shi, Okayama, Japan
    - Recruiting
    - Eisai Trial Site 11
  - Okayama-shi, Okayama, Japan
    - Recruiting
    - Eisai Trial Site 13
  - Okayama-shi, Okayama, Japan
    - Recruiting
    - Eisai Trial Site 170
  - Okayama-shi, Okayama, Japan
    - Recruiting
    - Eisai Trial Site 40
- Okinawa
  - Nakagami-gun, Okinawa, Japan
    - Recruiting
    - Eisai Trial Site 17
  - Uruma-shi, Okinawa, Japan
    - Recruiting
    - Eisai Trial Site 96
- Osaka
  - Hirakata-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 160
  - Izumi-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 178
  - Izumisano-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 48
  - Kawachinagano-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 58
  - Moriguchi-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 65
  - Osaka-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 112
  - Osaka-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 122
  - Osaka-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 141
  - Osaka-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 147
  - Osaka-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 161
  - Osaka-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 171
  - Osaka-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 183
  - Osaka-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 29
  - Osaka-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 52
  - Osaka-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 59
  - Osakasayama-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 21
  - Suita-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 130
  - Takatsuki-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 60
  - Toyonaka-shi, Osaka, Japan
    - Recruiting
    - Eisai Trial Site 97
- Saitama
  - Hidaka-shi, Saitama, Japan
    - Recruiting
    - Eisai Trial Site 144
  - Iruma-gun, Saitama, Japan
    - Recruiting
    - Eisai Trial Site 140
  - Koshigaya-shi, Saitama, Japan
    - Recruiting
    - Eisai Trial Site 74
  - Saitama-shi, Saitama, Japan
    - Recruiting
    - Eisai Trial Site 148
  - Tokorozawa-shi, Saitama, Japan
    - Recruiting
    - Eisai Trial Site 138
- Shiga
  - Otsu-shi, Shiga, Japan
    - Recruiting
    - Eisai Trial Site 177
  - Ritto-shi, Shiga, Japan
    - Recruiting
    - Eisai Trial Site 102
- Shizuoka
  - Izunokuni-shi, Shizuoka, Japan
    - Recruiting
    - Eisai Trial Site 39
  - Shimada-shi, Shizuoka, Japan
    - Recruiting
    - Eisai Trial Site 143
  - Shizuoka-shi, Shizuoka, Japan
    - Recruiting
    - Eisai Trial Site 87
  - Sunto-gun, Shizuoka, Japan
    - Recruiting
    - Eisai Trial Site 22
- Tochigi
  - Shimotsuga-gun, Tochigi, Japan
    - Recruiting
    - Eisai Trial Site 34
- Tokushima
  - Tokushima-shi, Tokushima, Japan
    - Recruiting
    - Eisai Trial Site 100
  - Tokushima-shi, Tokushima, Japan
    - Recruiting
    - Eisai Trial Site 182
  - Tokushima-shi, Tokushima, Japan
    - Recruiting
    - Eisai Trial Site 64
- Tokyo
  - Bunkyo-ku, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 154
  - Bunkyo-ku, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 72
  - Bunkyo-ku, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 77
  - Chuo-ku, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 1
  - Edogawa-ku, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 106
  - Itabashi-ku, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 78
  - Komae-shi, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 120
  - Koto-ku, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 32
  - Minato-ku, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 146
  - Minato-ku, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 15
  - Minato-ku, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 49
  - Mitaka-shi, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 126
  - Musashino-shi, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 89
  - Ome-shi, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 135
  - Shinagawa-Ku, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 149
  - Shinagawa-Ku, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 23
  - Shinjuku-ku, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 158
  - Shinjuku-ku, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 80
  - Suginami-ku, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 155
  - Suginami-ku, Tokyo, Japan
    - Recruiting
    - Eisai Trial Site 156
- Tottori
  - Yonago-shi, Tottori, Japan
    - Recruiting
    - Eisai Trial Site 82
- Toyama
  - Toyama-shi, Toyama, Japan
    - Recruiting
    - Eisai Trial Site 101
  - Toyama-shi, Toyama, Japan
    - Recruiting
    - Eisai Trial Site 57
- Wakayama
  - Tanabe-shi, Wakayama, Japan
    - Recruiting
    - Eisai Trial Site 139
  - Wakayama-shi, Wakayama, Japan
    - Recruiting
    - Eisai Trial Site 47
  - Wakayama-shi, Wakayama, Japan
    - Recruiting
    - Eisai Trial Site 69
- Yamagata
  - Sakata-shi, Yamagata, Japan
    - Recruiting
    - Eisai Trial Site 19
  - Yamagata-shi, Yamagata, Japan
    - Recruiting
    - Eisai Trial Site 62

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Participants with a history of hypersensitivity to any ingredient of Tazverik

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Tazemetostat oral tablets. Other Names: Tazverik

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Drug Reactions (ADRs) Time Frame: 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.	Up to Week 52
Number of Participants With Serious ADRs Time Frame: 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.	Up to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With ADRs Based on Participant Background Factors Time Frame: 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.	Up to Week 52
Percentage of Participants with Overall Response Time Frame: 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.	Up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2021

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

E7438-M081-501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma, Follicular

Joseph Tuscano
National Cancer Institute (NCI); Genentech, Inc.; Pharmacyclics LLC.

Recruiting

Obinutuzumab, Ibrutinib, and Venetoclax for the Treatment of Previously Untreated Stage II-IV Follicular Lymphoma

Ann Arbor Stage II Follicular Lymphoma | Ann Arbor Stage III Follicular Lymphoma | Ann Arbor Stage IV Follicular Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Grade 3a Follicular Lymphoma

United States
National Cancer Institute (NCI)

Recruiting

Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma

Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Grade 3a Follicular Lymphoma

United States
Memorial Sloan Kettering Cancer Center
Fox Chase Cancer Center; Pharmacyclics LLC.

Terminated

Ibrutinib for Patients With Follicular Lymphoma Without Complete Response to Initial Chemoimmunotherapy

Follicular Lymphoma | Follicular Lymphoma, Grade 1 | Follicular Lymphoma, Grade 2 | Follicular Lymphoma Grade IIIa

United States
National Cancer Institute (NCI)

Terminated

Rituximab and Oblimersen in Treating Patients With Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma

Stage III Grade 1 Follicular Lymphoma | Stage III Grade 2 Follicular Lymphoma | Stage III Grade 3 Follicular Lymphoma | Stage IV Grade 1 Follicular Lymphoma | Stage IV Grade 2 Follicular Lymphoma | Stage IV Grade 3 Follicular Lymphoma

United States
Robert Lowsky
National Cancer Institute (NCI); Janssen, LP; The Leukemia and Lymphoma Society; Rising Tide Foundation

Completed

TLR9 Agonist SD-101, Ibrutinib, and Radiation Therapy in Treating Patients With Relapsed or Refractory Grade 1-3A Follicular Lymphoma

Mantle Cell Lymphoma | Marginal Zone Lymphoma | Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Grade 3a Follicular Lymphoma

United States
Olivia Newton-John Cancer Research Institute
Bristol-Myers Squibb; Barwon Health; Austin Health; Eastern Health; Fiona Stanley... and other collaborators

Recruiting

Treatment Of Newly-diagnosed Follicular Lymphoma With CELMoD BMS-986369, Rituximab +/- Nivolumab. (TOP-FLOR)

Follicular Lymphoma Stage II | Follicular Lymphoma Stage III | Follicular Lymphoma Stage IV

Australia
Fondazione Italiana Linfomi ONLUS

Completed

"MIRO" Molecularly Oriented Immuno-radio-therapy (FIL_MIRO)

Follicular Lymphoma, Grade 1 | Follicular Lymphoma, Grade 2 | Follicular Lymphoma Grade 3A

Italy
Epizyme, Inc.

Recruiting

Study of Tazemetostat Versus Placebo When Given in Combination With Lenalidomide and Rituximab in Participants With Relapsed/Refractory Follicular Lymphoma (SYMPHONY-1)

Follicular Lymphoma | Relapsed/Refractory Follicular Lymphoma | Refractory Follicular Lymphoma

United States, China, Spain, France, Taiwan, United Kingdom, Australia, Korea, Republic of, Canada, Italy, Hungary, Poland, Belgium, Germany
Massachusetts General Hospital
TG Therapeutics

Active, not recruiting

Umbralisib and Rituximab as Initial Therapy for Patients With Follicular Lymphoma and Marginal Zone Lymphoma

Lymphoma | Follicular Lymphoma | Marginal Zone Lymphoma | Follicular Lymphoma, Grade 1 | Follicular Lymphoma Grade IIIa | Marginal Zone B Cell Lymphoma | Follicular Lymphoma Grade 2

United States
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Active, not recruiting

Acalabrutinib, Lenalidomide, and Rituximab for the Treatment of CD20 Positive Stage III-IV, Grade 1-3a Follicular Lymphoma

Grade 3a Follicular Lymphoma | Ann Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann Arbor Stage III Grade 3 Follicular Lymphoma | Ann Arbor Stage...

United States

Clinical Trials on Tazemetostat

Loma Linda University

Withdrawn

Tazemetostat for the Treatment of Moderate to Severe COVID-19 Infection (IST)

Cytokine Release Syndrome | COVID-19 Acute Respiratory Distress Syndrome
Hutchison Medipharma Limited

Recruiting

Tazemetostat for the Treatment of Relapsed/Refractory Follicular Lymphoma

Relapsed/Refractory Follicular Lymphoma With EZH2

China
Prisma Health-Upstate
Ipsen

Recruiting

Phase II Study of Tazemetostat in Solid Tumors Harboring an ARID1A Mutation

Solid Tumor | ARID1A Gene Mutation

United States
Epizyme, Inc.
WEP Clinical

No longer available

Tazemetostat Expanded Access Program for Adults With Epithelioid Sarcoma

Epithelioid Sarcoma
Eisai Co., Ltd.

Completed

A Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

Japan
Eisai Co., Ltd.

Completed

Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation

Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

Japan
Weill Medical College of Cornell University
Epizyme, Inc.; American Society of Clinical Oncology; Applebaum Foundation

Recruiting

A Feasibility Trial of Tazemetostat Plus CAR T Cell Therapy in B-cell Lymphomas

Follicular Lymphoma | Mantle Cell Lymphoma | Diffuse Large B Cell Lymphoma | B-Cell Lymphoma

United States
University of Florida
Epizyme, Inc.

Recruiting

Tazemetostat in Malignant Peripheral Nerve Sheath Tumors

Peripheral Nerve Sheath Tumor

United States
National Cancer Institute (NCI)
Children's Oncology Group

Active, not recruiting

Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial)

Recurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Rhabdoid Tumor | Advanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Ann Arbor Stage III Hodgkin Lymphoma | Ann Arbor Stage IV Hodgkin Lymphoma | Recurrent Ependymoma | Recurrent Ewing Sarcoma | Recurrent Hepatoblastoma | Recurrent... and other conditions

United States, Puerto Rico
Epizyme, Inc.
Ipsen

Not yet recruiting

A Study to Assess Efficacy and Safety of Oral Tazemetostat in Adult Participants With Relapsed/Refractory Follicular Lymphoma That Does Not Have an "EZH2 Gain-of-function" Genetic Mutation (Mandolin)

Follicular Lymphoma | Refractory Follicular Lymphoma

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

A Post-marketing Observational Study of Tazemetostat on Safety in Patients With Relapsed or Refractory Follicular Lymphoma With EZH2 Gene Mutation in Japan

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Clinical Trials on Lymphoma, Follicular

Clinical Trials on Tazemetostat

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations