Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation
Study Details
Study Description
Brief Summary
This is a multicenter, open-label, Phase 2 study to assess the efficacy and safety of tazemetostat in participants with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) with EZH2 gene mutation.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 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. |
Drug: Tazemetostat
Tazemetostat will be provided as a 200 mg oral tablet.
|
Experimental: 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. |
Drug: Tazemetostat
Tazemetostat will be provided as a 200 mg oral tablet.
|
Outcome Measures
Primary Outcome Measures
- Objective response rate (ORR) [From administration of the first dose of the study drug until disease progression, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent, or study termination (up to 30 months)]
ORR is defined as the number of participants with a best overall response of complete response or partial response.
Secondary Outcome Measures
- Progression-free survival (PFS) [From administration of the first dose of the study drug to the date of the first event (disease progression, death, etc.) (up to 30 months)]
- Duration of response (DOR) [From confirmation of the first response to the date of the first event (disease progression, death, etc.) (up to 30 months)]
- Time to response (TTR) [From administration of the first dose of the study drug to confirmation of the first response (up to 30 months)]
- Number of participants with any adverse event, as an assessment of safety [From administration of the first dose of the study drug to 30 days after the last dose (up to 30 months)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants with histological diagnosis of B-cell non-Hodgkin's lymphoma (NHL) as follows:
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Cohort 1: Follicular lymphoma (FL)
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Cohort 2: Diffuse large B-cell lymphoma (including primary mediastinal B-cell lymphoma and transformed FL)
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Participants who have confirmed EZH2 gene mutation of tumor in central laboratory
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Participants who have measurable disease
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Participants who had previous therapy with systemic chemotherapy and/or antibody therapy and for which no standard therapy exists
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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
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Participants with Eastern Cooperative Oncology Group performance status of 0 to 1
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Participants with life expectancy of ≥3 months from starting study drug administration
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Participants with adequate renal, liver, and bone marrow function
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Male and female participants ≥20 years of age at the time of informed consent
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Participants who has provided written consent to participate in the study
Exclusion Criteria:
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Participants with prior exposure to EZH2 inhibitor
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Participants with a history or a presence of central nerves invasion
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Participants with malignant pleural effusion, cardiac effusion, or ascites retention
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Participants with allogeneic stem cell transplantation
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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)
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Participants with significant cardiovascular impairment
· Participants with prolongation of corrected QT interval using Fridericia's formula to > 480 milliseconds (msec)
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Participants with venous thrombosis or pulmonary embolism within the last 3 months before starting study drug
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Participants with complications of hepatic cirrhosis, interstitial pneumonia or pulmonary fibrosis
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Participants with active infection requiring systemic therapy
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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
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Woman who are pregnant or breastfeeding
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Participants who were deemed as inappropriate to participate in the study by the investigator or sub-investigator
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Have any prior history of T-cell lymphoblastic lymphoma/T-cell acute lymphoblastic leukemia or myeloid malignancies, including myelodysplastic syndrome
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | 1004 Eisai Trial Site | Nagoya | Aichi | Japan | |
2 | 1029 Eisai Trial Site | Nagoya | Aichi | Japan | |
3 | 1020 Eisai Trial Site | Ota | Gunma | Japan | |
4 | 1007 Eisai Trial Site | Sapporo | Hokkaido | Japan | |
5 | 1019 Eisai Trial Site | Kobe | Hyogo | Japan | |
6 | 1005 Eisai Trial Site | Tsukuba | Ibaraki | Japan | |
7 | 1002 Eisai Trial Site | Isehara | Kanagawa | Japan | |
8 | 1028 Eisai Trial Site | Yokohama | Kanagawa | Japan | |
9 | 1021 Eisai Trial Site | Sendai | Miyagi | Japan | |
10 | 1013 Eisai Trial Site | Osakasayama | Osaka | Japan | |
11 | 1006 Eisai Trial Site | Suita | Osaka | Japan | |
12 | 1027 Eisai Trial Site | Suntou-gun | Shizuoka | Japan | |
13 | 1026 Eisai Trial Site | Bunkyo-ku | Tokyo | Japan | |
14 | 1001 Eisai Trial Site | Chuo-ku | Tokyo | Japan | |
15 | 1025 Eisai Trial Site | Koto-ku | Tokyo | Japan | |
16 | 1017 Eisai Trial Site | Minato-ku | Tokyo | Japan | |
17 | 1022 Eisai Trial Site | Aomori | Japan | ||
18 | 1010 Eisai Trial Site | Chiba | Japan | ||
19 | 1012 Eisai Trial Site | Fukuoka | Japan | ||
20 | 1016 Eisai Trial Site | Fukuoka | Japan | ||
21 | 1011 Eisai Trial Site | Hiroshima | Japan | ||
22 | 1024 Eisai Trial Site | Kumamoto | Japan | ||
23 | 1003 Eisai Trial Site | Kyoto | Japan | ||
24 | 1008 Eisai Trial Site | Kyoto | Japan | ||
25 | 1023 Eisai Trial Site | Nagasaki | Japan | ||
26 | 1009 Eisai Trial Site | Okayama | Japan | ||
27 | 1015 Eisai Trial Site | Osaka | Japan | ||
28 | 1018 Eisai Trial Site | Yamagata | Japan |
Sponsors and Collaborators
- Eisai Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E7438-J081-206