NCT06522737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
SecuraBio74 个研究点 分布在 10 个国家目标入组 124 人开始时间: 2025年5月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 74
- 主要终点
- Progression-free Survival (PFS) as assessed by the Independent Review Committee (IRC)
研究概览
简要总结
The study will evaluate the progression-free survival benefit of duvelisib monotherapy as compared to investigator's choice of gemcitabine or bendamustine in participants with relapsed/refractory nodal T cell lymphoma with TFH phenotype.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •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.
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.
- •Other protocol-defined criteria apply.
研究组 & 干预措施
Duvelisib
Experimental
Duvelisib will be administered orally twice daily (BID) in 28-day cycles.
干预措施: Duvelisib (Drug)
Gemcitabine or Bendamustine
Active Comparator
Participants will receive the investigator's choice of gemcitabine or bendamustine. The regimen to be used after randomization must be selected by the investigator prior to randomization. Gemcitabine will be administered intravenously (IV) on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles. Bendamustine will be administered IV on days 1 and 2 of each 21-day cycle for up to 6 cycles.
干预措施: Gemcitabine (Drug)
Gemcitabine or Bendamustine
Active Comparator
Participants will receive the investigator's choice of gemcitabine or bendamustine. The regimen to be used after randomization must be selected by the investigator prior to randomization. Gemcitabine will be administered intravenously (IV) on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles. Bendamustine will be administered IV on days 1 and 2 of each 21-day cycle for up to 6 cycles.
干预措施: Bendamustine (Drug)
结局指标
主要结局
Progression-free Survival (PFS) as assessed by the Independent Review Committee (IRC)
时间窗: 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)
- Number of participants with Adverse Events (AEs)(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)
- Concentration of Duvelisib and its Metabolites in Blood(Day 1 of Cycle 1 and Cycle 2 (predose and 60 minutes postdose))
研究者
研究点 (74)
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相关资讯
Secura Bio Reports Sustained Efficacy of Duvelisib in Heavily Pretreated Peripheral T-Cell Lymphoma Patients- Extended follow-up analyses from the Phase 2 PRIMO trial demonstrate duvelisib maintains clinical activity across all treatment-experienced PTCL populations, including patients with ≥3 prior lines of therapy.
- Safety profile remains manageable with longer treatment duration, showing no consistent pattern of increased adverse events over time.
- Results support the ongoing Phase 3 TERZO trial in nodal T-follicular helper cell lymphoma, which is actively enrolling at over 40 European centers.9 months agoPhase 3 TERZO Trial to Evaluate Duvelisib in Rare T-Cell Lymphoma Following Promising Phase 2 Results- The upcoming TERZO trial will assess duvelisib against standard chemotherapy in patients with nodal T-cell lymphoma with follicular helper T phenotype, addressing a significant treatment gap in rare lymphomas.
- Phase 2 PRIMO study demonstrated promising results with duvelisib showing a 48% overall response rate and 33.3% complete response rate in relapsed/refractory PTCL patients.
- The TERZO trial aims to enroll 124 patients across EU and UK, with progression-free survival as the primary endpoint, potentially leading to regulatory approval if successful.last yearDuvelisib Shows Promise in Relapsed/Refractory Peripheral T-Cell Lymphoma- Phase 2 PRIMO trial data showed duvelisib achieved a 48% overall response rate and a 33% complete response rate in R/R PTCL patients.
- AITL subgroup analysis revealed a 62% ORR and 51% CR, suggesting enhanced efficacy in T-follicular helper cell lymphoma.
- Secura Bio plans to initiate a Phase 3 trial (TERZO) to evaluate duvelisib in R/R nodal T-follicular helper cell lymphoma.
- The safety profile of duvelisib in the PRIMO trial was consistent with previous studies, with manageable adverse events.last year