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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Tazemetostat
Sponsored by
Eisai Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma focused on measuring EZH2 gene mutation, Tazemetostat, Diffuse large B-cell lymphoma, Follicular lymphoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1004 Eisai Trial Site
  • 1029 Eisai Trial Site
  • 1020 Eisai Trial Site
  • 1007 Eisai Trial Site
  • 1019 Eisai Trial Site
  • 1005 Eisai Trial Site
  • 1002 Eisai Trial Site
  • 1028 Eisai Trial Site
  • 1021 Eisai Trial Site
  • 1013 Eisai Trial Site
  • 1006 Eisai Trial Site
  • 1027 Eisai Trial Site
  • 1026 Eisai Trial Site
  • 1001 Eisai Trial Site
  • 1025 Eisai Trial Site
  • 1017 Eisai Trial Site
  • 1022 Eisai Trial Site
  • 1010 Eisai Trial Site
  • 1012 Eisai Trial Site
  • 1016 Eisai Trial Site
  • 1011 Eisai Trial Site
  • 1024 Eisai Trial Site
  • 1003 Eisai Trial Site
  • 1008 Eisai Trial Site
  • 1023 Eisai Trial Site
  • 1009 Eisai Trial Site
  • 1015 Eisai Trial Site
  • 1018 Eisai Trial Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

FL with EZH2 gene mutation

DLBCL with EZH2 gene mutation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) Based on Independent Reviewer Assessment
ORR was defined as percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using independent reviewer assessment based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in sum of diameters (SOD) of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% confidence interval (CI) was calculated by Clopper-Pearson method.
ORR Based on Investigator Assessment
ORR was defined as percentage of participants with confirmed BOR of CR or PR using investigator assessment based on RECIST 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis <10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% CI was calculated by Clopper-Pearson method.

Secondary Outcome Measures

Progression-free Survival (PFS) Based on Independent Reviewer Assessment
PFS was assessed by independent reviewer assessment based on RECIST 1.1. PFS was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD or death, whichever occurred first. PD for target lesion, a minimum 20% increase and a minimum 5 mm absolute increase in SOD compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir: Lowest measure SOD of target lesion at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
PFS Based on Investigator Assessment
PFS was assessed by investigator assessment based on RECIST 1.1. PFS was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD or death, whichever occurred first. PD for target lesion, a minimum 20% increase and a minimum 5 mm absolute increase in SOD compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir: Lowest measure SOD of target lesion at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
Duration of Response (DOR) Based on Independent Reviewer Assessment
DOR: time from date of confirmation of the first response and the date of confirmation of the PD using independent reviewer assessment as per RECIST 1.1. BOR of CR and PR was confirmed by subsequent CR assessment and CR or PR assessment, respectively at least 4 weeks later. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes had to be reduced in short axis to <10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD, there are no unequivocal new lesions, and no progression of non-target disease. PD for target lesion, a minimum 20% increase and a minimum 5mm absolute increase in SOD compared to nadir, or PD for non-target lesions or unequivocal new lesions. Nadir: Lowest measure SOD of target lesions at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
DOR Based on Investigator Assessment
DOR: time from date of confirmation of the first response and the date of confirmation of the PD using independent reviewer assessment as per RECIST 1.1. BOR of CR and PR was confirmed by subsequent CR assessment and CR or PR assessment, respectively at least 4 weeks later. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes had to be reduced in short axis to <10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD, there are no unequivocal new lesions, and no progression of non-target disease. PD for target lesion, a minimum 20% increase and a minimum 5mm absolute increase in SOD compared to nadir, or PD for non-target lesions or unequivocal new lesions. Nadir: Lowest measure SOD of target lesions at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
Time to Response (TTR) Based on Independent Reviewer Assessment
TTR was defined as the time from the first dose of the study drug to date of first observation of CR or PR using independent reviewer assessment based on RECIST 1.1. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to <10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease.
TTR Based on Investigator Assessment
TTR was defined as the time from the first dose of the study drug to date of first observation of CR or PR using investigator assessment based on RECIST 1.1. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to <10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease.
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAE is defined as an AE that emerged during time from the first dose of study drug to 30 days after the participant's last dose. An AE was any untoward medical occurrence in participant administered with an investigational product. An SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening; requires participant hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).

Full Information

First Posted
March 6, 2018
Last Updated
November 18, 2022
Sponsor
Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03456726
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
December 17, 2021 (Actual)
Study Completion Date
December 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Keywords
EZH2 gene mutation, Tazemetostat, Diffuse large B-cell lymphoma, Follicular lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FL with EZH2 gene mutation
Arm Type
Experimental
Arm Description
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.
Arm Title
DLBCL with EZH2 gene mutation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tazemetostat
Intervention Description
Tazemetostat will be provided as a 200 mg oral tablet.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) Based on Independent Reviewer Assessment
Description
ORR was defined as percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using independent reviewer assessment based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in sum of diameters (SOD) of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% confidence interval (CI) was calculated by Clopper-Pearson method.
Time Frame
From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)
Title
ORR Based on Investigator Assessment
Description
ORR was defined as percentage of participants with confirmed BOR of CR or PR using investigator assessment based on RECIST 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis <10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% CI was calculated by Clopper-Pearson method.
Time Frame
From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) Based on Independent Reviewer Assessment
Description
PFS was assessed by independent reviewer assessment based on RECIST 1.1. PFS was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD or death, whichever occurred first. PD for target lesion, a minimum 20% increase and a minimum 5 mm absolute increase in SOD compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir: Lowest measure SOD of target lesion at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
Time Frame
From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)
Title
PFS Based on Investigator Assessment
Description
PFS was assessed by investigator assessment based on RECIST 1.1. PFS was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD or death, whichever occurred first. PD for target lesion, a minimum 20% increase and a minimum 5 mm absolute increase in SOD compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir: Lowest measure SOD of target lesion at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
Time Frame
From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)
Title
Duration of Response (DOR) Based on Independent Reviewer Assessment
Description
DOR: time from date of confirmation of the first response and the date of confirmation of the PD using independent reviewer assessment as per RECIST 1.1. BOR of CR and PR was confirmed by subsequent CR assessment and CR or PR assessment, respectively at least 4 weeks later. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes had to be reduced in short axis to <10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD, there are no unequivocal new lesions, and no progression of non-target disease. PD for target lesion, a minimum 20% increase and a minimum 5mm absolute increase in SOD compared to nadir, or PD for non-target lesions or unequivocal new lesions. Nadir: Lowest measure SOD of target lesions at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
Time Frame
From the date of first confirmed objective response (OR) to PD or death due to confirmed PR or CR (up to 3 years 4 months)
Title
DOR Based on Investigator Assessment
Description
DOR: time from date of confirmation of the first response and the date of confirmation of the PD using independent reviewer assessment as per RECIST 1.1. BOR of CR and PR was confirmed by subsequent CR assessment and CR or PR assessment, respectively at least 4 weeks later. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes had to be reduced in short axis to <10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD, there are no unequivocal new lesions, and no progression of non-target disease. PD for target lesion, a minimum 20% increase and a minimum 5mm absolute increase in SOD compared to nadir, or PD for non-target lesions or unequivocal new lesions. Nadir: Lowest measure SOD of target lesions at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
Time Frame
From the date of first confirmed OR to PD or death due to any cause for those participants with a confirmed PR or CR (up to 3 years 4 months)
Title
Time to Response (TTR) Based on Independent Reviewer Assessment
Description
TTR was defined as the time from the first dose of the study drug to date of first observation of CR or PR using independent reviewer assessment based on RECIST 1.1. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to <10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease.
Time Frame
From the date of first dose until date of first observation of CR or PR (up to 3 years 4 months)
Title
TTR Based on Investigator Assessment
Description
TTR was defined as the time from the first dose of the study drug to date of first observation of CR or PR using investigator assessment based on RECIST 1.1. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to <10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease.
Time Frame
From the date of first dose until date of first observation of CR or PR (up to 3 years 4 months)
Title
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
TEAE is defined as an AE that emerged during time from the first dose of study drug to 30 days after the participant's last dose. An AE was any untoward medical occurrence in participant administered with an investigational product. An SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening; requires participant hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).
Time Frame
From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
1004 Eisai Trial Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
1029 Eisai Trial Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
1020 Eisai Trial Site
City
Ota
State/Province
Gunma
Country
Japan
Facility Name
1007 Eisai Trial Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
1019 Eisai Trial Site
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
1005 Eisai Trial Site
City
Tsukuba
State/Province
Ibaraki
Country
Japan
Facility Name
1002 Eisai Trial Site
City
Isehara
State/Province
Kanagawa
Country
Japan
Facility Name
1028 Eisai Trial Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
1021 Eisai Trial Site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
1013 Eisai Trial Site
City
Osakasayama
State/Province
Osaka
Country
Japan
Facility Name
1006 Eisai Trial Site
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
1027 Eisai Trial Site
City
Suntou-gun
State/Province
Shizuoka
Country
Japan
Facility Name
1026 Eisai Trial Site
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
1001 Eisai Trial Site
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Facility Name
1025 Eisai Trial Site
City
Koto-ku
State/Province
Tokyo
Country
Japan
Facility Name
1017 Eisai Trial Site
City
Minato-ku
State/Province
Tokyo
Country
Japan
Facility Name
1022 Eisai Trial Site
City
Aomori
Country
Japan
Facility Name
1010 Eisai Trial Site
City
Chiba
Country
Japan
Facility Name
1012 Eisai Trial Site
City
Fukuoka
Country
Japan
Facility Name
1016 Eisai Trial Site
City
Fukuoka
Country
Japan
Facility Name
1011 Eisai Trial Site
City
Hiroshima
Country
Japan
Facility Name
1024 Eisai Trial Site
City
Kumamoto
Country
Japan
Facility Name
1003 Eisai Trial Site
City
Kyoto
Country
Japan
Facility Name
1008 Eisai Trial Site
City
Kyoto
Country
Japan
Facility Name
1023 Eisai Trial Site
City
Nagasaki
Country
Japan
Facility Name
1009 Eisai Trial Site
City
Okayama
Country
Japan
Facility Name
1015 Eisai Trial Site
City
Osaka
Country
Japan
Facility Name
1018 Eisai Trial Site
City
Yamagata
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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