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

NCT07282548 | Withdrawn

• 1 other identifier: CLIN-60200-456
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (11)

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

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

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

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

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

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

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

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

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

  At Day 1

Study Arms (1)

Tazemetostat Monotherapy Group

Participants 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 15, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2031
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the United States (US) and/or European Union (EU).
• Access Criteria: Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).