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

Study identification

• EU PAS number:
  EUPAS1000000766
• Study ID:
  1000000766
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study aims to evaluate the effectiveness of the medicine Tazemetostat following at least two lines of treatment 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 EZH2 gene (known as EZH2 wild-type versus mutant-type).;
• Study status:
  Cancelled

Study timelines

Date when funding contract was signed

Planned:29/07/2025

Actual:29/07/2025

Study start date

Planned:16/06/2026

Date of final study report

Planned:31/03/2032

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable