2024-516605-23-00招募中3 期
A multicentre, open-label, Phase 3, randomised controlled trial of duvelisib versus investigator’s choice of gemcitabine or bendamustine in patients with relapsed/refractory nodal T cell lymphoma with T follicular helper (TFH) phenotype (TERZO)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 39
- 主要终点
- Progression-free Survival (PFS) according to the Lugano 2014 criteria (Cheson 2014) as assessed by the Independent Review Committee (IRC) or death due to any cause - Up to 3 years
研究概览
简要总结
To evaluate the Independent Review Committee (IRC)-determined progression-free survival (PFS) benefit of duvelisib monotherapy as compared to investigator’s choice of gemcitabine or bendamustine
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Pathologically confirmed nodal T cell lymphoma with TFH phenotype according to the criteria of the World Health Organization classification (Swerdlow 2017, Alaggio 2022) including any one of Angioimmunoblastic T cell lymphoma (AITL), follicular T cell lymphoma, and other nodal peripheral T cell lymphoma (PTCL) with a TFH phenotype.
- •Relapsed or refractory to at least 1 prior systemic, cytotoxic therapy for T cell lymphoma.
- •Measurable disease as defined by Lugano 2014 criteria (Cheson 2014) for T cell lymphoma
- •ECOG Performance Status 0, 1 or 2
排除标准
- •Cutaneous-only disease
- •Received prior allogeneic transplant any time in the past or received autologous transplant within 60 days prior to the first dose of study drug
- •Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor
- •Prior exposure to planned study treatment investigator's choice therapy (gemcitabine or bendamustine) within 60 days prior to the first dose of study drug
- •Pregnant or breastfeeding
结局指标
主要结局
Progression-free Survival (PFS) according to the Lugano 2014 criteria (Cheson 2014) as assessed by the Independent Review Committee (IRC) or death due to any cause - Up to 3 years
Progression-free Survival (PFS) according to the Lugano 2014 criteria (Cheson 2014) as assessed by the Independent Review Committee (IRC) or death due to any cause - Up to 3 years
次要结局
- Overall Survival (OS) - Up to 3 years
- PFS as assessed by the investigator - Up to 3 years
- Objective Response Rate (ORR) as assessed by the IRC - Up to 3 years
- Complete Response Rate (CRR) as assessed by the IRC - Up to 3 years
- Duration of Response (DOR) as assessed by the IRC - Up to 3 years
- Proportion of participants who proceed to Stem Cell Transplantation (SCT) - Up to 3 years
- Investigator-assessed PFS in participants who proceed to SCT - Up to 3 years
- Incidence/frequency of Adverse Events (AEs) and abnormal laboratory values - Up to 3 years
- Quality of Life (QoL): European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score - Up to 3 years
- QoL: EQ5D Score - Up to 3 years
- QoL: QLQ-NHL-HG29 Score - Up to 3 years
研究者
Head of Clinical Development
Scientific
Secura Bio Limited
研究点 (39)
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