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 will study 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 will 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.
Stage 1 of the study, which is now completed, looked at the safety and tolerability of the drug combinations and helped determine the recommended dose for the next stages. In Stage 2, participants will be grouped based on whether they have a specific genetic mutation called EZH2. All participants will receive treatment in 28-day cycles. After 12 cycles, they will continue with maintenance treatment using either the study drug or a placebo, depending on their original group. The study will include participants with and without the EZH2 mutation. Enrollment may be completed separately for each group. In China, some participants will also have extra blood tests to better understand how the drug behaves in the body. Stage 3 will focus on long-term follow-up to monitor how well the treatment works, how safe it is, and how long participants live. All participants will be followed for up to 5 years after the last person joins the study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
612
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.
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.
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
RECRUITINGArizona Oncology Associates - Tuscon-Rusadill Road
Tucson, Arizona, United States
RECRUITINGTOI - Clinical Research
Cerritos, California, United States
RECRUITINGUCSF Fresno
Clovis, California, United States
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 will be evaluated. RP3D of tazemetostat for further evaluation in phase 3 will be 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
Progression-Free Survival (PFS) in the Intent-to-treat wild-type (ITT-WT) 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
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
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)
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)
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)
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)
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)
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).
Time frame: Stage 2: Up to 96 months
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.
Time frame: Stage 2: Up to 96 months
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.
Time frame: Stage 2: Up to 96 months
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.
Time frame: Stage 2: Up to 96 months
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.
Time frame: Stage 2: Up to 96 months
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.
Time frame: Stage 2: Up to 96 months
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
OS in the ITT-MT population
Time frame: Stage 2: Up to 96 months
OS in the R/R FL population regardless of mutation status
Time frame: Stage 2: Up to 96 months
PFS in the ITT-WT population, assessed by a blinded IRC
Time frame: Stage 2: Up to 96 months
PFS in the ITT-MT population, assessed by a blinded IRC
Time frame: Stage 2: Up to 96 months
PFS in the R/R FL population regardless of mutation status, assessed by a blinded IRC
Time frame: Stage 2: Up to 96 months
PFS in the R/R FL population regardless of mutation status, assessed by the Investigator
Time frame: Stage 2: Up to 96 months
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.
Time frame: Stage 2: Up to 96 months
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.
Time frame: Stage 2: Up to 96 months
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.
Time frame: Stage 2: Up to 96 months
Duration Of Complete Response (DOCR) in the ITT-WT population
DOCR is defined as the time from initial CR to documented progression or death due to any cause, whichever occurs first, for those participants with CR, assessed by the Investigator and by a blinded IRC.
Time frame: Stage 2: Up to 96 months
DOCR in the ITT-MT population
DOCR is defined as the time from initial CR to documented progression or death due to any cause, whichever occurs first, for those participants with CR, assessed by the Investigator and by a blinded IRC.
Time frame: Stage 2: Up to 96 months
DOCR in the R/R FL population regardless of mutation status
DOCR is defined as the time from initial CR to documented progression or death due to any cause, whichever occurs first, for those participants with CR, assessed by the Investigator and by a blinded IRC.
Time frame: Stage 2: Up to 96 months
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.
Time frame: Stage 2: Up to 96 months
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.
Time frame: Stage 2: Up to 96 months
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.
Time frame: Stage 2: Up to 96 months
Population PK parameters of oral clearance (CL/F) of tazemetostat
CL/F will be used to generate estimates of tazemetostat AUC
Time frame: Stage 2: In cycles 2, 4, 6, and 12 at Day 1 (28 days cycle)
Population PK parameters of oral volume of distribution (Vd/F) of tazemetostat.
Time frame: Stage 2: In cycles 2, 4, 6, and 12 at Day 1 (28 days cycle)
Population PK parameters of first-order absorption rate constant (Ka) for tazemetostat.
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
Duration of exposure to study drug will be reported.
Time frame: Up to 36 months
Percentage of study drug taken by participants
Time frame: Up to 36 months
Quality of life questionnaires evaluation
Evaluate and compare health-related quality of life as measured by the EuroQOL 5-Dimension 5-Level (EQ-5D-5L) instrument and the Functional Assessment of Cancer Therapy -Lymphoma (FACT-Lym)
Time frame: Up to 36 months
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UC San Diego Health Sciences
La Jolla, California, United States
RECRUITINGUCLA Clinical Research Unit Hematology/Oncology
Santa Monica, California, United States
RECRUITINGRocky Mountain Cancer Centers (RMCC) - Boulder
Boulder, Colorado, United States
RECRUITINGSt. Mary's Hospital and Regional Medical Center - St. Mary's
Grand Junction, Colorado, United States
RECRUITINGSCL Health Lutheran Medical Center
Greeley, Colorado, United States
WITHDRAWNCancer Specialists of North Florida
Fleming Island, Florida, United States
RECRUITING...and 219 more locations