Skip to main content
OpenTrials
Completed

NCT Number: NCT05467943

Tazemetostat for the Treatment of Relapsed/Refractory Follicular Lymphoma

Treating Relapsed/Refractory Follicular Lymphoma with Tazemetostat

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Relapsed/Refractory Follicular Lymphoma With EZH2 Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure;
  • Age ≥18 years;
  • Patients with histologically confirmed R/R FL (Grades 1, 2, 3a)
  • Patients must have one measurable lesion
  • Life expectancy ≥ 12 weeks;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
  • Adequate bone marrow function, renal function and hepatic function:
  • Currently human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or cytomegalovirus (CMV) is inactive:
  • Female patients of childbearing potential must agree to adopt dual contraceptive method

Exclusion criteria

  • Previous use of Tazemetostat or other EZH2 inhibitors;
  • Patients with invasion of lymphoma to the central nervous system (CNS) or the pia mater;
  • Previous bone marrow malignancies,
  • Abnormalities associated with MDS and myeloproliferative neoplasms observed by cytogenetic testing and DNA sequencing;

Treatment and study plan

Tazemetostat

Drug

All patients will receive 800 mg of Tazemetostat, BID, administered in continuous 28-day therapeutic cycle

Primary outcomes

  1. efficacy of Tazemetostat in EZH2 (MT) (Cohort 1)

    Time frame: 22 months

    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]

Secondary outcomes

  1. efficacy of Tazemetostat in EZH2 (WT) (Cohort 2)

    Time frame: 22 months

    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.

  2. safety of Tazemetostat in EZH2 (WT) (Cohort 2)

    Time frame: 22 months

    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.

  3. Geomean maximum concentration (Cmax) of tazemetostat and its metabolite EPZ-6930 in blood

    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.

    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.

  4. Median time to reach maximum concentration (Tmax) of tazemetostat and its metabolite EPZ-6930 in blood

    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.

    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.

  5. Geomean area under the drug concentration-time curve (AUC) of tazemetostat and its metabolite EPZ-6930 after administration of tazemetostat

    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

    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.

  6. Geomean minimum observed concentration at steady-state (Cmin) of tazemetostat and its metabolite EPZ-6930 in blood

    Time frame: Cycle1Day15, Cycle2Day1 and Cycle3Day1: predose of first administration

    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.

Sponsors and collaborators

Lead sponsor

Hutchmed

Industry

Registry information

Official study title

A Multicenter, Open-label, Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Tazemetostat for the Treatment of Patients With Relapsed/Refractory Follicular Lymphoma

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2022
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.