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Relapsed/Refractory Follicular Lymphoma With EZH2Phase 2NCT05467943

Tazemetostat for the Treatment of Relapsed/Refractory Follicular Lymphoma

A Phase 2 study testing Tazemetostat in people with Relapsed/Refractory Follicular Lymphoma With EZH2, run by Hutchmed at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Treating Relapsed/Refractory Follicular Lymphoma with Tazemetostat Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tazemetostat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteChina
Study dates
29 Jul 2022to 30 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official 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

Treating Relapsed/Refractory Follicular Lymphoma with Tazemetostat

Read the detailed description

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.

Being tested
Tazemetostat
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TazemetostatDrug

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

Study groups in NCT05467943
Study groupRoleWhat they receive
Cohort 1 based on the EZH2 mutationsExperimentalMT patients with R/R FL; planned enrollment number: 19;
Receives: Drug: Tazemetostat
Cohort 2 based on the EZH2 mutations,ExperimentalWT patients with R/R FL; planned enrollment number: 20;
Receives: Drug: Tazemetostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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]

    Measured: 22 months

Secondary outcomes (6)

  1. 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.

    Measured: 22 months

  2. 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.

    Measured: 22 months

  3. 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.

    Measured: 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.

  4. 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.

    Measured: 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.

  5. 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.

    Measured: 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

  6. 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.

    Measured: Cycle1Day15, Cycle2Day1 and Cycle3Day1: predose of first administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2022
  2. Study start29 Jul 2022
  3. Primary completion30 Nov 2024
  4. Study completion30 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
All patients will be enrolled to Cohort 1 and 2 based on the EZH2 mutations, respectively: * Cohort 1: MT patients with R/R FL; planned enrollment number: 19; * Cohort 2: WT patients with R/R FL; planned enrollment number: 20; Both cohorts have same dose administered: 800 mg, twice per day (BID), continuously, at a suggested interval of 12 hours between two doses.
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05467943
Sponsor's protocol ID
2021-TAZ-00CH1
Status last verified
Jan 2025
First submitted
28 Jun 2022
Last updated
23 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cao J, Chen G, Qiu L, Zhang L, Jiang M, Cheng Y, Zhang Q, Liu L, Li P, Shuang Y, Wang H, Xue H, Wu H, Zheng M, Zhou K, Li Z, Jing H, Yang W, Zhu Z, Li W, Wangwu J, Huang H, Jia Q, Chen D, Fan S, Shi MM, Su W. Efficacy and safety of tazemetostat, an EZH2 inhibitor, in Chinese patients with relapsed/refractory follicular lymphoma: a multicentre, single-arm, phase 2 study. EClinicalMedicine. 2025 Aug 18;87:103399. doi: 10.1016/j.eclinm.2025.103399. eCollection 2025 Sep.

    PubMed 40896460

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tazemetostat in people with Relapsed/Refractory Follicular Lymphoma With EZH2, run by Hutchmed at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

efficacy of Tazemetostat in EZH2 (MT) (Cohort 1) (time frame: 22 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05467943, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.

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