Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation
NCT ID: NCT03456726
Last Updated: 2022-12-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2018-04-09
2021-12-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FL with EZH2 gene mutation
Participants with follicular lymphoma (FL) with the EZH2 gene mutation will receive oral tazemetostat at a starting dose of 800 milligrams (mg) twice daily (1600 mg total daily dose) by continuous regimen, no less than 8 hours between doses.
Tazemetostat
Tazemetostat will be provided as a 200 mg oral tablet.
DLBCL with EZH2 gene mutation
Participants with diffuse large B-cell lymphoma (DLBCL) with the EZH2 gene mutation will receive oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) by continuous regimen, no less than 8 hours between doses.
Tazemetostat
Tazemetostat will be provided as a 200 mg oral tablet.
Interventions
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Tazemetostat
Tazemetostat will be provided as a 200 mg oral tablet.
Eligibility Criteria
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Inclusion Criteria
* Cohort 1: Follicular lymphoma (FL)
* Cohort 2: Diffuse large B-cell lymphoma (including primary mediastinal B-cell lymphoma and transformed FL)
* Participants who have confirmed EZH2 gene mutation of tumor in central laboratory
* Participants who have measurable disease
* Participants who had previous therapy with systemic chemotherapy and/or antibody therapy and for which no standard therapy exists
* Participants who had progressive disease or did not have response (complete response or partial response) in previous systemic therapy, or relapsed or progressed after previous systemic therapy
* Participants with Eastern Cooperative Oncology Group performance status of 0 to 1
* Participants with life expectancy of ≥3 months from starting study drug administration
* Participants with adequate renal, liver, and bone marrow function
* Male and female participants ≥20 years of age at the time of informed consent
* Participants who has provided written consent to participate in the study
Exclusion Criteria
* Participants with a history or a presence of central nerves invasion
* Participants with malignant pleural effusion, cardiac effusion, or ascites retention
* Participants with allogeneic stem cell transplantation
* Participants with medical need for the continued use of potent inhibitors of Cytochrome P450 3A (CYP3A)or potent inducer of CYP3A (including St. John's wort)
* Participants with significant cardiovascular impairment
· Participants with prolongation of corrected QT interval using Fridericia's formula to \> 480 milliseconds (msec)
* Participants with venous thrombosis or pulmonary embolism within the last 3 months before starting study drug
* Participants with complications of hepatic cirrhosis, interstitial pneumonia or pulmonary fibrosis
* Participants with active infection requiring systemic therapy
* Women of childbearing potential or man of impregnate potential who don't agree that both the participant and his/her partner will use a medically effective method for contraception for periods from before informed consent to during the clinical study and 30 days later (for males 90 days later) from last administration of study drug
* Woman who are pregnant or breastfeeding
* Participants who were deemed as inappropriate to participate in the study by the investigator or sub-investigator
* Have any prior history of T-cell lymphoblastic lymphoma/T-cell acute lymphoblastic leukemia or myeloid malignancies, including myelodysplastic syndrome
20 Years
ALL
No
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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1004 Eisai Trial Site
Nagoya, Aichi-ken, Japan
1029 Eisai Trial Site
Nagoya, Aichi-ken, Japan
1020 Eisai Trial Site
Ōta, Gunma, Japan
1007 Eisai Trial Site
Sapporo, Hokkaido, Japan
1019 Eisai Trial Site
Kobe, Hyōgo, Japan
1005 Eisai Trial Site
Tsukuba, Ibaraki, Japan
1002 Eisai Trial Site
Isehara, Kanagawa, Japan
1028 Eisai Trial Site
Yokohama, Kanagawa, Japan
1021 Eisai Trial Site
Sendai, Miyagi, Japan
1013 Eisai Trial Site
Sayama, Osaka, Japan
1006 Eisai Trial Site
Suita, Osaka, Japan
1027 Eisai Trial Site
Suntou-gun, Shizuoka, Japan
1026 Eisai Trial Site
Bunkyo-ku, Tokyo, Japan
1001 Eisai Trial Site
Chuo-ku, Tokyo, Japan
1025 Eisai Trial Site
Koto-ku, Tokyo, Japan
1017 Eisai Trial Site
Minato-ku, Tokyo, Japan
1022 Eisai Trial Site
Aomori, , Japan
1010 Eisai Trial Site
Chiba, , Japan
1012 Eisai Trial Site
Fukuoka, , Japan
1016 Eisai Trial Site
Fukuoka, , Japan
1011 Eisai Trial Site
Hiroshima, , Japan
1024 Eisai Trial Site
Kumamoto, , Japan
1003 Eisai Trial Site
Kyoto, , Japan
1008 Eisai Trial Site
Kyoto, , Japan
1023 Eisai Trial Site
Nagasaki, , Japan
1009 Eisai Trial Site
Okayama, , Japan
1015 Eisai Trial Site
Osaka, , Japan
1018 Eisai Trial Site
Yamagata, , Japan
Countries
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References
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Izutsu K, Ando K, Nishikori M, Shibayama H, Goto H, Kuroda J, Kato K, Imaizumi Y, Nosaka K, Sakai R, Abe M, Hojo S, Nakanishi T, Rai S. Tazemetostat for relapsed/refractory B-cell non-Hodgkin lymphoma with EZH2 mutation in Japan: 3-year follow-up for a phase II study. Int J Hematol. 2024 Nov;120(5):621-630. doi: 10.1007/s12185-024-03834-9. Epub 2024 Aug 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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E7438-J081-206
Identifier Type: -
Identifier Source: org_study_id