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.
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
Drug | Synonyms | Arms |
---|
Tazemetostat | | DLBCL 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
Name | Type | Description | Interventions |
---|
FL with EZH2 gene mutation | Experimental | 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. | |
DLBCL with EZH2 gene mutation | Experimental | 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. | |
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
- Have any prior history of T-cell lymphoblastic lymphoma/T-cell acute lymphoblastic
leukemia or myeloid malignancies, including myelodysplastic syndrome
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: | Active, not recruiting |
Lead Sponsor: | Eisai Co., Ltd. |
Trial Keywords
- EZH2 gene mutation
- Tazemetostat
- Diffuse large B-cell lymphoma
- Follicular lymphoma
Last Updated
July 28, 2021