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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Ipsen
- 入组人数
- 63
- 主要终点
- Real-world Objective Response Rate (rwORR) stratified by EZH2 mutation status.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Real-world Objective Response Rate (rwORR) stratified by EZH2 mutation status.
时间窗: Fom first dose to end of study participation, which may range from 1 day to up to 5 years.
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.
次要结局
- 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)
- Percentage of participants with dose reductions and reasons for reduction stratified by EZH2 mutation status.(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.(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.(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.(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.(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)(From first dose until 30 days after last dose.)