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Diffuse Large B-cell Lymphoma (DLBCL)Phase 1/2TRuSTNCT02875548

A Study to Assess Long-term Safety of Tazemetostat in Adult Participants of All Ages With Any Disease Treated With Tazemetostat in a Previous Clinical Study

A Phase 1/2 study testing Tazemetostat in people with Diffuse Large B-cell Lymphoma (DLBCL) and Follicular Lymphoma (FL), run by Epizyme, Inc. at 34 sites in 7 countries.

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

This study will provide continuing availability to tazemetostat for people that have previously completed participation in a tazemetostat study, either with monotherapy (single drug treatment) or combination therapy. The aim of the study will be to assess the long-term safety of tezemetostat. 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
58 participants
Where
34 sitesin 7 countries
Study dates
30 Aug 2016to 26 Sep 2025
Phase
Phase 1/2
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

  • Subjects must meet ALL criteria to be eligible for enrollment in this study.
  • Has demonstrated and continues to demonstrate clinical benefit from treatment with tazemetostat.
  • Is currently receiving tazemetostat as either monotherapy or in combination with other approved drug(s) or investigational agent(s) on an Epizyme-sponsored clinical trial or any other clinical trial being conducted with tazemetostat that is not sponsored by Epizyme (including but not limited to, investigator-initiated trials). For subjects on combination therapy, treatment with other therapeutic(s) must have been completed in the antecedent study or will be provided by a source other than Epizyme if combination therapeutics are continued in this study until disease progression, treatment toxicity, subject preference or death, up to approximately 7 years.
  • Has voluntarily provided signed written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.
  • Has a life expectancy of ≥3 months.
  • Has adequate hematologic, (bone marrow [BM] and coagulation factors), renal, and hepatic function. Subject must remain eligible for continued treatment with tazemetostat according to the eligibility and treatment criteria from the antecedent study

Who cannot join

  • Subjects meeting ANY of the following criteria must NOT be enrolled in this study:
  • Has had an interruption of tazemetostat dosing of >14 days from the antecedent clinical study to starting the rollover study unless approved by the Medical Monitor.
  • Has another malignancy other than the one for which they are receiving tazemetostat.
  • Exception: Subject who has been disease-free of a prior malignancy for 5 years or subject with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma is eligible.
  • Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE v5 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).
  • Has a prior history of T-LBL/T-ALL.

Trial locations and contacts

34 sites in 7 countries.

34 sites in 7 countries

United States11 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Central Care Cancer Center

    Bolivar, Missouri, 65613

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Astera Cancer Center

    East Brunswick, New Jersey, 08816

  • Columbia University Medical Center

    New York, New York, 10019

  • David H. Koch Center for Cancer Care at memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Hematology Oncology Associates of the Treasure Coast - Port St. Lucie

    Port Saint Lucie, Florida, 34952

  • California Cancer Associates For Research And Excellence, cCARE

    Santa Fe, California, 92024

  • Moffitt

    Tampa, Florida, 33612

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724

Other trials in United States

France9 sites

  • Institut Bergonie

    Bordeaux, 33076

  • CHU de Caen - Hôpital Côte de Nacre

    Caen, 14033

  • CHRU de Lile- Hopital Claude Huriez

    Lille, 59037

  • CHU de Montpellier - Hopital Saint Eloi

    Montpellier

  • Hôpital Saint Louis - AP-HP

    Paris, 75010

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

  • CHU Rennes- Hopital Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • Gustave Roussay

    Villejuif, 94805

Other trials in France

Australia5 sites

  • Princess Alexandra Hospital

    Alexandra

  • Monash Medical Centre- Monash Campus

    Clayton, 3168

  • Geelong Hospital

    Geelong

  • Peter MacCallum Cancer Institute

    Melbourne, 3002

  • Monash Health

    Monash

Other trials in Australia

United Kingdom5 sites

  • Beatson, West of Scotland Cancer Centre

    Glasgow

  • Oncology and Haematology Clinical Trials Unit

    Leicester, LEI 5WW

  • Clatterbridge Cancer Centre

    Liverpool, L7 8XP

  • Hammersmith Hospital

    London, W12 0HS

  • The Christie NHS Foundation Trust

    Manchester

Other trials in United Kingdom

Poland2 sites

  • Pratia MCM Krakow

    Krakow, 30-510

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Endokrynologii Onkologicznej i Medycyny Nuklearnej

    Warsaw

Other trials in Poland

Belgium1 site

  • University Hospital (UZ) Leuven

    Leuven, 3000

Other trials in Belgium

Ukraine1 site

  • S.P. Grigoreva Institute of Medical Radiology and Oncology of NAMS of Ukraine"

    Kharkiv, 61024

Other trials in Ukraine

About this study

Official title: Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study

This study will provide continuing availability to tazemetostat for people that have previously completed participation in a tazemetostat study, either with monotherapy (single drug treatment) or combination therapy.

The aim of the study will be to assess the long-term safety of tezemetostat.

Read the detailed description

This open-label, multicenter, global study will provide continuing access to tazemetostat therapy for subjects who have completed their participation in a prior tazemetostat study (either with monotherapy or combination therapy)

without unacceptable toxicity, have not had evidence of tumor progression as defined by disease-appropriate standard criteria, and continue to receive clinical benefit from the therapy.

Subjects will receive tazemetostat as dictated in their antecedent study. Visits will be conducted per Standard of Care (SoC) as appropriate in each country and as determined by the Investigator. Subjects will be followed for long-term safety in addition to time to treatment failure (TTF) and overall survival (OS).

Being tested
Tazemetostat
Keywords
Epizyme, Tazverik, Tazemetostat (EPZ-6438)
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Sarcoma, Synovial, Mesothelioma, Lymphoma, Non-Hodgkin

What participants receive

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

  • TazemetostatDrug

    Also called EPZ-6438, E7438, IPN60200

    Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of enhancer of Zeste homolog 2 (EZH2), a histone-lysine N-methyltransferase enzyme.

Study groups in NCT02875548
Study groupRoleWhat they receive
Open-label TazemetostatExperimentalParticipants will continue to receive the same tazemetostat dose and schedule as specified in their antecedent tazemetostat protocol. For participants on combination therapy, the other therapeutic(s) must have been completed in the antecedent study or be provided by a source other than Epizyme if combination treatment is continued in this clinical rollover study.
Receives: Drug: Tazemetostat

What is being measured

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

  1. Percentage of Participants with Adverse Events (AEs) and Treatment Emergent Adverse Event (TEAEs)

    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 Severity of adverse events experienced by all participants will be evaluated by the Investigator based on the CTCAE, version 5.0.

    Measured: Until end of study an average of 7 years

  2. Duration of Study Drug Exposure

    The average study drug exposure duration will be reported.

    Measured: Until end of study an average of 7 years

Secondary outcomes (1)

  1. The overall survival (OS)

    Defined as the interval of time between the date of the first dose of tazemetostat and the date of death due to any cause

    Measured: Until end of study an average of 7 years

Timeline

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

  1. First posted23 Aug 2016 (estimated)
  2. Study start30 Aug 2016
  3. Primary completion26 Sep 2025
  4. Study completion26 Sep 2025

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02875548
Sponsor's protocol ID
EZH-501
Other IDs
2015-004984-35, 2023-510553-41-00, 2023, 2015
Acronym
TRuST
Status last verified
Oct 2025
First submitted
5 Aug 2016
Last updated
4 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tazemetostat in people with Diffuse Large B-cell Lymphoma (DLBCL) and Follicular Lymphoma (FL), run by Epizyme, Inc. at 34 sites in 7 countries.

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 6 inclusion and 6 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 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, France, Australia, United Kingdom, Poland and 2 more countries. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Percentage of Participants with Adverse Events (AEs) and Treatment Emergent Adverse Event (TEAEs) (time frame: Until end of study an average of 7 years). The study lists 2 primary outcomes in all. 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 NCT02875548.

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 4 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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