The participants of this study would have relapsed/refractory follicular lymphoma. Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after a period of improvement after that follows a treatment regimen and 'refractory' when treatment no longer works. Stage 1 of this trial studied the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3. Stage 1 of the study is completed. Stages 2 and 3 were designed to evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo (dummy drug) in combination with other drug treatment. However, following an urgent safety measure, treatment with tazemetostat and placebo was discontinued, enrollment was stopped, and the study was unblinded. As a result, post-urgent safety measure analyses are descriptive in nature.
In Stage 2, participants were enrolled into study cohorts based on whether they have a specific genetic mutation in the EZH2 gene. All participants received treatment in 28-day cycles. After 12 cycles, they continued with maintenance treatment using either the study drug or placebo, depending on their original treatment group. However, following the urgent safety measure, treatment was permanently discontinued and no further interventional procedures are being conducted. The study included participants with and without the mutation in EZH2 gene. Enrollment was to be completed separately for each group. In China, some participants also had extra blood tests to better understand how the drug behaves in the body; no further pharmacokinetic data are being collected following the urgent safety measure. Stage 3 focuses on long-term safety monitoring after the urgent safety measure. Participants treated with tazemetostat will be followed for up to 5 years after the last dose of tazemetostat
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
599
Stage 1 (Phase 1b): Tazemetostat was escalated from a starting dose of 400 mg orally twice daily to 600 mg orally twice daily to 800 mg PO twice daily in 28-day cycles as tolerated in a standard 3 + 3 design. Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy. Following implementation of the urgent safety measure, tazemetostat administration was discontinued. No further dosing is performed.
Stage 2: Tazemetostat 800 mg administered orally twice daily in continuous 28-day cycles for 12 cycles. Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy.
Stage 2: Placebo administered orally twice daily in continuous 28-day cycles. Placebo will be administered as monotherapy twice daily dose for up to 2 years after the initial 12 months of combination therapy. Following implementation of the urgent safety measure, placebo administration was discontinued.
Lenalidomide 20 mg capsules or 10 mg capsules (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles.
Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5.
Southern Cancer Center
Mobile, Alabama, United States
Arizona Oncology Associates - Tuscon-Rusadill Road
Tucson, Arizona, United States
TOI - Clinical Research
Cerritos, California, United States
UCSF Fresno
Clovis, California, United States
UC San Diego Health Sciences
La Jolla, California, United States
Phase 1b: Recommended Phase 3 Dose (RP3D) of tazemetostat in combination with rituximab and lenalidomide (R2)
The safety and tolerability of tazemetostat in combination with R2 in subjects with R/R FL were evaluated. RP3D of tazemetostat for further evaluation in phase 3 was selected as assessed by the occurrence of treatment-emergent dose-limiting toxicities (DLTs) and adverse events (AEs).
Time frame: Subjects are evaluated for DLTs during the first 28-day cycle. The RP3D for Phase 3 was selected at the end of Stage 1
Phase 3: Progression-Free Survival (PFS) in the Intent-to-treat wild-type (ITT-WT) populations
PFS is defined as the time from the date of randomization to the time of confirmed disease progression per the 2014 Lugano Classification or death, whichever occurs first, as assessed by Investigators. PFS will be assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further efficacy data are collected, and any post-urgent safety measure analyses are descriptive in nature.
Time frame: Stage 2: Up to 72 months
Phase 3: PFS in the Intent-to-treat mutant-type (ITT-MT) population
PFS is defined as the time from the date of randomization to the time of confirmed disease progression per the 2014 Lugano Classification or death, whichever occurs first, as assessed by Investigators.
Time frame: Stage 2: Up to 72 months
Phase 3: PFS in the R/R FL population regardless of mutation status by Investigator assessment
PFS is defined as the time from the date of randomization to the first observation of documented objective disease progression per the 2014 Lugano Classification or death due to any cause, whichever occurs first. PFS is defined as the time from the date of randomization to the time of confirmed disease progression per the 2014 Lugano Classification or death, whichever occurs first, as assessed by Investigators.
Time frame: Stage 2: Up to 72 months
Phase 3: Progression-Free Survival (PFS) in the all comer (ITT-All) populations.
PFS is defined as the time from the date of randomization to the time of confirmed disease progression per the 2014 Lugano Classification or death, whichever occurs first, as assessed by Investigators. PFS will be assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further efficacy data are collected, and any post-urgent safety measure analyses are descriptive in nature.
Time frame: Stage 2: Up to 72 months
Phase 1b: Pharmacokinetics (PK) of tazemetostat: Maximum (peak) Observed Plasma Drug Concentration (Cmax).
Cmax will be recorded from the PK blood samples collected.
Time frame: Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
Phase 1b: PK of tazemetostat, EPZ 6930 (desethyl metabolite), and lenalidomide as data permit: Time to Maximum Observed Drug Concentration (Tmax)
Time frame: Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
Phase 1b: PK of tazemetostat: area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration [AUC(0-t)],
Time frame: Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
Phase 1b: PK of tazemetostat: area under the plasma concentration-time curve (AUC) from time 0 to infinity [AUC(0-∞)]
Time frame: Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
Phase 1b: The apparent terminal elimination half-life (t1/2) of tazemetostat, EPZ 6930 (desethyl metabolite), and lenalidomide as data permit
Time frame: Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
Phase 3: Complete Response Rate (CRR) in ITT-WT population
CRR is defined as the proportion of participants achieving CR according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded Independent Review Committee (IRC). CRR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature.
Time frame: Stage 2: Up to 96 months
Phase 3: CRR in ITT-MT population
CRR is defined as the proportion of participants achieving CR according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC. CRR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature.
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UCLA Clinical Research Unit Hematology/Oncology
Santa Monica, California, United States
Rocky Mountain Cancer Centers (RMCC) - Boulder
Boulder, Colorado, United States
St. Mary's Hospital and Regional Medical Center - St. Mary's
Grand Junction, Colorado, United States
Cancer Specialists of North Florida
Fleming Island, Florida, United States
Florida Cancer Specialists & Research Institute (FCS) - Fort Myers Cancer Center
Fort Myers, Florida, United States
...and 194 more locations
Time frame: Stage 2: Up to 96 months
Phase 3: CRR in the Relapsed/Refractory (R/R) Follicular Lymphoma (FL) population regardless of mutation status
CRR is defined as the proportion of participants achieving CR according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC. CRR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature.
Time frame: Stage 2: Up to 96 months
Phase 3: Objective Response Rate (ORR) in the ITT-WT population
ORR is defined as the proportion of participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR) according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC. ORR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature.
Time frame: Stage 2: Up to 96 months
Phase 3: ORR in the ITT-MT population
ORR is defined as the proportion of participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR) according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC. ORR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature.
Time frame: Stage 2: Up to 96 months
Phase 3: ORR in the R/R FL population regardless of mutation status
ORR is defined as the proportion of participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR) according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC. ORR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature.
Time frame: Stage 2: Up to 96 months
Phase 3: Overall Survival (OS) in the ITT-WT population
OS is defined as the time from the date of randomization until death due to any cause.
Time frame: Stage 2: Up to 96 months
Phase 3: OS in the ITT-MT population
Time frame: Stage 2: Up to 96 months
Phase 3: OS in the R/R FL population regardless of mutation status
Time frame: Stage 2: Up to 96 months
Phase 3: PFS in the ITT-WT population, assessed by a blinded IRC
Time frame: Stage 2: Up to 96 months
Phase 3: PFS in the ITT-MT population, assessed by a blinded IRC
Time frame: Stage 2: Up to 96 months
Phase 3: PFS in the R/R FL population regardless of mutation status, assessed by a blinded IRC
Time frame: Stage 2: Up to 96 months
Phase 3: Duration Of Response (DOR) in the ITT-WT population
DOR is defined as the time from initial CR or PR to documented progression or death due to any cause, whichever occurs first, for those participants with a CR or PR, as assessed by the Investigator and by a blinded IRC. DOR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature.
Time frame: Stage 2: Up to 96 months
Phase 3: DOR in the ITT-MT population
DOR is defined as the time from initial CR or PR to documented progression or death due to any cause, whichever occurs first, for those participants with a CR or PR, as assessed by the Investigator and by a blinded IRC. DOR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature.
Time frame: Stage 2: Up to 96 months
Phase 3: DOR in the R/R FL population regardless of mutation status
DOR is defined as the time from initial CR or PR to documented progression or death due to any cause, whichever occurs first, for those participants with a CR or PR, as assessed by the Investigator and by a blinded IRC. DOR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature.
Time frame: Stage 2: Up to 96 months
Phase 3: Disease Control Rate (DCR) in the ITT-WT population
DCR, defined as the proportion of participants with best overall response of CR, PR, or stable disease (SD) lasting 12 or more months, as assessed by the Investigator and by a blinded IRC. DCR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature.
Time frame: Stage 2: Up to 96 months
Phase 3: DCR in the ITT-MT population
DCR, defined as the proportion of participants with best overall response of CR, PR, or stable disease (SD) lasting 12 or more months, as assessed by the Investigator and by a blinded IRC. DCR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature.
Time frame: Stage 2: Up to 96 months
Phase 3: DCR in the R/R FL population regardless of mutation status
DCR, defined as the proportion of participants with best overall response of CR, PR, or stable disease (SD) lasting 12 or more months, as assessed by the Investigator and by a blinded IRC. DCR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature.
Time frame: Stage 2: Up to 96 months
PK parameters will be summarized by plasma concentrations of tazemetostat and lenalidomide descriptively.
PK assessments will be conducted on samples collected until the urgent safety measure. No further PK analyses are performed post-urgent safety measure.
Time frame: Stage 2: In cycles 2, 4, 6, and 12 at Day 1 (28 days cycle)
Percentage of Participants Experiencing Adverse Events (AEs)
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to 36 months
Percentage of Participants with Clinically Significant Changes in Physical Examination
Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be graded by the investigator according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 5.0.
Time frame: Up to 36 months
Percentage of Participants with Clinically Significant Changes in Vital Signs
Percentage of participants with clinically significant changes in vital signs findings will be reported. The clinical significance will be graded by the investigator according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 5.0.
Time frame: Up to 36 months
Percentage of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Readings
Percentage of participants with clinically significant changes in ECG Readings will be reported. The clinical significance will be graded by the investigator according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 5.0.
Time frame: Up to 72 months
Performance status evaluated by Eastern Cooperation Oncology Group (ECOG)
ECOG is a 6-point performance status scale used to assess performance using PA as a key indicator (e.g., 0 = fully active, 2 = up and about more than 50% of walking hours, 5 = dead) Performance status will be assessed per usual clinical practice and will be recorded in the medical record.
Time frame: Up to 72 months
Duration of Study Drug Exposure
Study drug exposure reflects administration prior to implementation of the urgent safety measure. No further investigational drug exposure occurs post-urgent safety measure.
Time frame: Up to 36 months