A Phase 2 interventional study of Tazemetostat in Relapsed/Refractory Follicular Lymphoma With EZH2, sponsored by Hutchmed. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by Hutchmed · Phase 2, Interventional, and Treatment
Treating Relapsed/Refractory Follicular Lymphoma with Tazemetostat
This is an open-label, monotherapy, Phase II Study clinical study. The objective is to evaluate the efficacy, safety, and pharmacokinetics of Tazemetostat in the treatment of patients with relapsed/refractory follicular lymphoma. It is planned to enroll 39 Chinese patients in 2 cohorts.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 42 is close to the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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Exclusion Criteria:
MT patients with R/R FL; planned enrollment number: 19;
Drug: Tazemetostat
WT patients with R/R FL; planned enrollment number: 20;
Drug: Tazemetostat
All patients will receive 800 mg of Tazemetostat, BID, administered in continuous 28-day therapeutic cycle
efficacy of Tazemetostat in EZH2 (MT) (Cohort 1)
Objective response rate (ORR) of Cohort 1 evaluated by the Independent Review Committee (IRC) \[based on the International Working Group-Non-Hodgkin's Lymphoma \[IWG-NHL\] (Cheson) 2007\]
Time frame: 22 months
efficacy of Tazemetostat in EZH2 (WT) (Cohort 2)
Overall survival (OS) of Cohort 1 and 2. OS: defined as the time from the first dose of study drug to death for any cause.
Time frame: 22 months
safety of Tazemetostat in EZH2 (WT) (Cohort 2)
The incidence and severity of treatment emergent adverse events (TEAEs). Occurrence of AEs (including SAEs) will be monitored based on the changes in vital signs, physical examination, 12-lead ECG and laboratory examinations. The severity of AEs will be graded based on NCI CTCAE V5.0.
Time frame: 22 months
Geomean maximum concentration (Cmax) of tazemetostat and its metabolite EPZ-6930 in blood
Cmax is defined as the maximum observed concentration that a drug achieves in a test area of the body after the drug has been administered. Plasma concentration-time profiles of tazemetostat and EPZ-6930 will be plotted using non-compartmental analysis and will be analyzed to determine Cmax. Cmax will be summarized as the geomean and geomean CV% for all participants.
Time frame: Cycle1Day1: predose of first administration; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. Cycle1Day15: predose of first administration ; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. Cycle2Day1 and Cycle3Day1: predose of first administration.
Median time to reach maximum concentration (Tmax) of tazemetostat and its metabolite EPZ-6930 in blood
Tmax is defined as the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered. Plasma concentration-time profiles of tazemetostat and EPZ-6930 will be plotted using non-compartmental analysis and will be analyzed to determine Tmax. Tmax will be summarized as the median (min, max) for all participants.
Time frame: Cycle1Day 1: predose of first administration; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. Cycle1Day15: predose of first administration; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. Cycle2Day1 and Cycle3Day1: predose of first administration.
Geomean area under the drug concentration-time curve (AUC) of tazemetostat and its metabolite EPZ-6930 after administration of tazemetostat
AUC represents the total drug exposure over a defined period of time. AUC will be calculated using the linear trapezoidal rule. Plasma concentrations of tazemetostat and EPZ-6930 will be analyzed using a non-compartmental analysis approach to determine individual participant estimates of AUC. AUC will be summarized as the geomean and geomean CV% for all participants.
Time frame: Cycle1Day1: predose of first administration; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. Cycle1Day15: predose of first administration; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose
Geomean minimum observed concentration at steady-state (Cmin) of tazemetostat and its metabolite EPZ-6930 in blood
Cmin is defined as the minimum observed concentration at steady-state during one dosing interval. Cmin will be summarized as the geomean and geomean CV% for all participants.
Time frame: Cycle1Day15, Cycle2Day1 and Cycle3Day1: predose of first administration
Plan to share: No
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