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

January 13, 2022 updated by: Eisai Co., Ltd.

A Phase 2 Study of Tazemetostat in Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

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

Study Locations

  • Japan
      • Aomori, Japan
        • 1022 Eisai Trial Site
      • Chiba, Japan
        • 1010 Eisai Trial Site
      • Fukuoka, Japan
        • 1012 Eisai Trial Site
      • Fukuoka, Japan
        • 1016 Eisai Trial Site
      • Hiroshima, Japan
        • 1011 Eisai Trial Site
      • Kumamoto, Japan
        • 1024 Eisai Trial Site
      • Kyoto, Japan
        • 1003 Eisai Trial Site
      • Kyoto, Japan
        • 1008 Eisai Trial Site
      • Nagasaki, Japan
        • 1023 Eisai Trial Site
      • Okayama, Japan
        • 1009 Eisai Trial Site
      • Osaka, Japan
        • 1015 Eisai Trial Site
      • Yamagata, Japan
        • 1018 Eisai Trial Site
    • Aichi
      • Nagoya, Aichi, Japan
        • 1004 Eisai Trial Site
      • Nagoya, Aichi, Japan
        • 1029 Eisai Trial Site
    • Gunma
      • Ota, Gunma, Japan
        • 1020 Eisai Trial Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • 1007 Eisai Trial Site
    • Hyogo
      • Kobe, Hyogo, Japan
        • 1019 Eisai Trial Site
    • Ibaraki
      • Tsukuba, Ibaraki, Japan
        • 1005 Eisai Trial Site
    • Kanagawa
      • Isehara, Kanagawa, Japan
        • 1002 Eisai Trial Site
      • Yokohama, Kanagawa, Japan
        • 1028 Eisai Trial Site
    • Miyagi
      • Sendai, Miyagi, Japan
        • 1021 Eisai Trial Site
    • Osaka
      • Osakasayama, Osaka, Japan
        • 1013 Eisai Trial Site
      • Suita, Osaka, Japan
        • 1006 Eisai Trial Site
    • Shizuoka
      • Suntou-gun, Shizuoka, Japan
        • 1027 Eisai Trial Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • 1026 Eisai Trial Site
      • Chuo-ku, Tokyo, Japan
        • 1001 Eisai Trial Site
      • Koto-ku, Tokyo, Japan
        • 1025 Eisai Trial Site
      • Minato-ku, Tokyo, Japan
        • 1017 Eisai Trial Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants with histological diagnosis of B-cell non-Hodgkin's lymphoma (NHL) as follows:

    • 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 prior exposure to EZH2 inhibitor
  • 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

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 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.
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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: 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)
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)
Time Frame: From confirmation of the first response to the date of the first event (disease progression, death, etc.) (up to 30 months)
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)
Time Frame: From administration of the first dose of the study drug to confirmation of the first response (up to 30 months)
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
Time Frame: From administration of the first dose of the study drug to 30 days after the last dose (up to 30 months)
From administration of the first dose of the study drug to 30 days after the last dose (up to 30 months)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 17, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 17, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E7438-J081-206

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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.

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