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Follicular LymphomaNCT07282548

Study of Tazemetostat in Adults With Follicular Lymphoma Previously Treated With at Least Two Therapies

An observational study of Follicular Lymphoma, run by Ipsen.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study aims to evaluate how well the effectiveness of the medicine Tazemetostat works in adults with relapsed/refractory follicular lymphoma, a slow-growing type of blood cancer that affects a kind of white blood cell called lymphocytes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
Type of treatment
Pill or oral medicine
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2026to 30 Jun 2031
Phase
Observational
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
  • Adult, Older adult

Study population: This study will enroll approximately 63 adult participants with relapsed or refractory follicular lymphoma (FL) grades 1, 2, or 3A. All participants must have received at least two prior lines of systemic therapy and be prescribed tazemetostat monotherapy in accordance with the approved U.S. Prescribing Information. The population includes both EZH2 wild-type and mutant cases, with mutation status either known at enrollment or determined during the study. Participants will be recruited from U.S.-based community oncology practices, hospital systems, and academic medical centers.

Who may be able to join

  • Adults aged 18 years or older
  • Histologically confirmed follicular lymphoma grades 1, 2, or 3A
  • At least two prior lines of systemic therapy
  • Prescribed tazemetostat according to United States prescribing information (USPI)
  • Known or planned EZH2 mutation status
  • Signed informed consent

Who cannot join

  • Grade 3B or transformed follicular lymphoma
  • Other hematologic malignancies
  • Use of strong/moderate Cytochrome P450 (CYP3A) inhibitors
  • Pregnant or breastfeeding
  • Participation in another investigational program

About this study

Official title: A Prospective Real-World Study Evaluating Objective Response Rate and Duration of Response of Tazemetostat Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma Following at Least Two Prior Lines of Treatment

This study aims to evaluate how well the effectiveness of the medicine Tazemetostat works in adults with relapsed/refractory follicular lymphoma, a slow-growing type of blood cancer that affects a kind of white blood cell called lymphocytes.

All participants will receive Tazemetostat as prescribed by their doctor in the routine clinical practice.

The study will observe how participants respond to the treatment, how long the response lasts, and monitor safety, side effects and how well participants tolerate the treatment.

Read the detailed description

The results will be analyzed based on whether or not participants have a mutation in the Enhancer of zeste homolog 2 (EZH2) gene (known as EZH2 wild-type).

Medical subject headings
Lymphoma, Follicular

What participants receive

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

Study groups in NCT07282548
Study groupRoleWhat they receive
Tazemetostat Monotherapy GroupParticipants with relapsed or refractory follicular lymphoma (grades 1, 2, or 3A) who have received at least two prior lines of systemic therapy and are prescribed tazemetostat monotherapy in accordance with the approved U.S. Prescribing Information. Tazemetostat is administered orally at 800 mg twice daily, as per routine clinical practice. Treatment continues until disease progression, unacceptable toxicity, or other discontinuation criteria are met.

What is being measured

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

  1. Real-world Objective Response Rate (rwORR) stratified by EZH2 mutation status.

    rwORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), assessed by the investigator using the Lugano 2014 classification.

    Measured: Fom first dose to end of study participation, which may range from 1 day to up to 5 years.

Secondary outcomes (11)

  1. Real-world Best Overall Response (rwBOR) stratified by EZH2 mutation status.

    rwBOR is defined as the best response assessed by the investigator using Lugano 2014 classification recorded from the start of treatment until disease progression or recurrence

    Measured: From first dose to end of study participation, which may range from 1 day to up to 5 years.

  2. Real-world Duration of Response (rwDOR) stratified by EZH2 mutation status.

    rwDOR is defined as the time from the first documented evidence of CR or PR until disease progression or death from any cause.

    Measured: Fom first dose to end of study participation, which may range from 1 day to up to 5 years.

  3. Real-world Progression-Free Survival (rwPFS) stratified by EZH2 mutation status.

    rwPFS is defined as the time from the start of treatment to the date of first documented disease progression or death from any cause.

    Measured: Fom first dose to end of study participation, which may range from 1 day to up to 5 years.

  4. Real-world Disease Control Rate (rwDCR) stratified by EZH2 mutation status.

    rwDCR is defined as the percentage of participants with CR, PR, or stable disease (SD) as their best response.

    Measured: Fom first dose to end of study participation, which may range from 1 day to up to 5 years.

  5. Percentage of participants starting at each initial dose level stratified by EZH2 mutation status.

    Measured: At Day 1

  6. Percentage of participants with dose reductions and reasons for reduction stratified by EZH2 mutation status.

    Measured: Fom first dose to end of study participation, which may range from 1 day to up to 5 years.

  7. Duration of treatment (in days/months) stratified by EZH2 mutation status.

    Measured: Fom first dose to end of study participation, which may range from 1 day to up to 5 years.

  8. Percentage of participants with treatment interruptions and associated reasons stratified by EZH2 mutation status.

    Measured: Fom first dose to end of study participation, which may range from 1 day to up to 5 years.

  9. Percentage of participants with treatment discontinuation and associated reasons stratified by EZH2 mutation status.

    Measured: Fom first dose to end of study participation, which may range from 1 day to up to 5 years.

  10. Percentage of participants receiving subsequent systemic therapy after Tazemetostat stratified by EZH2 mutation status.

    Measured: Fom last dose to end of study participation (up to 5 years).

  11. Percentage of participants experiencing Treatment Emergent Adverse Events (TEAEs), including Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)

    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. A TEAE is an AE for which the start date is on or after the date that the intervention began, or it was present prior to receiving the intervention but the intensity increased during the active phase of the study.

    Measured: From first dose until 30 days after last dose.

Timeline

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

  1. First posted15 Dec 2025
  2. Study startJun 2026 (estimated)
  3. Primary completion30 Jun 2031 (estimated)
  4. Study completion30 Jun 2031 (estimated)

Why it stopped: Withdrawn prior to enrolment after review of updated safety data

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07282548
Sponsor's protocol ID
CLIN-60200-456
Status last verified
Apr 2026
First submitted
27 Nov 2025
Last updated
29 Apr 2026
Results posted
No
FDA-regulated drug
No
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.

Questions about this trial

What is this clinical trial studying?

An observational study of Follicular Lymphoma, run by Ipsen.

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 5 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: withdrawn, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Real-world Objective Response Rate (rwORR) stratified by EZH2 mutation status. (time frame: Fom first dose to end of study participation, which may range from 1 day to up to 5 years.). 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 NCT07282548.

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 29 Apr 2026.

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