Clinical Trials /

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

NCT03456726

Description:

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.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation
  • Official Title: A Phase 2 Study of Tazemetostat in Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation

Clinical Trial IDs

  • ORG STUDY ID: E7438-J081-206
  • NCT ID: NCT03456726

Conditions

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

Interventions

DrugSynonymsArms
TazemetostatFL with EZH2 gene mutation

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
FL with EZH2 gene mutationExperimentalParticipants 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
DLBCL with EZH2 gene mutationExperimentalParticipants 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

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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)
Safety Issue:
Description:ORR is defined as the number of participants with a best overall response of complete response or partial response.

Secondary Outcome Measures

Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Eisai Co., Ltd.

Trial Keywords

  • EZH2 gene mutation
  • Tazemetostat
  • Diffuse large B-cell lymphoma
  • Follicular lymphoma

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