Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eisai Co., Ltd.
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation
