Clinical trial · Observational
Study of Tazemetostat in Adults With Follicular Lymphoma Previously Treated With at Least Two Therapies
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn prior to enrolment after review of updated safety data
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Tazemetostat Monotherapy Group
- description
- 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.
Primary outcomes (1)
- measure
- Real-world Objective Response Rate (rwORR) stratified by EZH2 mutation status.
- timeFrame
- Fom first dose to end of study participation, which may range from 1 day to up to 5 years.
- description
- 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.
Secondary outcomes (11)
- measure
- Real-world Best Overall Response (rwBOR) stratified by EZH2 mutation status.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available