An observational study in Follicular Lymphoma, sponsored by Ipsen. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Ipsen · Observational
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.
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).
931 studies on the registry are indexed under Lymphoma, Follicular; 237 are open to participants now.
Browse Lymphoma, Follicular studies →Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
Time frame: Fom first dose to end of study participation, which may range from 1 day to up to 5 years.
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
Time frame: 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.
rwDOR is defined as the time from the first documented evidence of CR or PR until disease progression or death from any cause.
Time frame: 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.
rwPFS is defined as the time from the start of treatment to the date of first documented disease progression or death from any cause.
Time frame: 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.
rwDCR is defined as the percentage of participants with CR, PR, or stable disease (SD) as their best response.
Time frame: 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.
Time frame: At Day 1
Percentage of participants with dose reductions and reasons for reduction 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.
Duration of treatment (in days/months) 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.
Percentage of participants with treatment interruptions and associated reasons 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.
Percentage of participants with treatment discontinuation and associated reasons 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.
Percentage of participants receiving subsequent systemic therapy after Tazemetostat stratified by EZH2 mutation status.
Time frame: Fom last dose to end of study participation (up to 5 years).
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.
Time frame: From first dose until 30 days after last dose.
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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