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New Genotype-guided Treatment in Newly Diagnosed PTCL (G08)

2026年7月11日 更新者：Zhao Weili、Ruijin Hospital

A New Genotype-guided Therapy in Newly Diagnosed Patients With Peripheral T-cell Lymphoma

This is a phase I/II study evaluate the safety and efficacy targeted agents in combination with standard CHOP in new genotypic subtypes in treatment naive peripheral T-cell lymphoma. Phase I is to confirm RP2D of targeted agent. Phase II is a multicenter, prospective, randomized, open-label, controlled design to evaluate the efficacy and safety of new genotype-guided targeted agents plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP-X2) versus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with peripheral T-cell lymphoma.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Peripheral T-cell lymphoma (PTCL) is a heterogeneous disease with dismal outcomes. Standard CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) chemotherapy is still the most widely used front-line treatment of PTCL except Brentuximab-CHP application in anaplastic large cell lymphoma (ALCL). The CR rate ranges from 31%-56% in different studies with different PTCL histology compositions. With the exception for ALCL-anaplastic lymphoma kinase (ALK)-positive, the 5-year overall survival (OS) rate is approximately 30%-40% for most subtypes of PTCL patients in current situation, remaining as the unmet medical needs in this disease. Based on genetic subtypes in PTCL, and our previous study exploring targeted agents plus CHOP based on genetic mutations (Guidance-03 and Guidance-04 study), we conducted this multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus CHOP (CHOP-X2) versus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with PTCL. It includes phase I and phase II stages. Patients will receceived stardard CHOP for the first cycle and then obtain the genetic subtypes from tumor NGS befor Cycle 2. In phase I, recommended phase 2 dose (RP2D) of targeted agents will be confirmed. In phase II, patients will receive standard CHOP for the first cycle and then 1:1 be randomized to CHOPX2 or CHOP regimen in four genetic subtypes.

研究类型

介入性

注册 (估计的)

108

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Weili Zhao Zhao
  • 电话号码：+862164370045 Ext. 610707
  • 邮箱：zwl_trial@163.com

学习地点

  • 中国
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200025
        • Ruijin Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Histologically-confirmed Peripheral T-cell lymphoma
  • Availability of archival or freshly collected tumor tissue before study enrollment enough for NGS
  • Evaluable lesion by PET-CT or CT scan
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Life expectancy greater than or equal to (>/=) 3 months
  • Informed consent

Exclusion Criteria:

  • Patients with ALCL and cutaneous TCL, MEITL, HSTCL, T-PLL, etc.
  • Patients with central nervous system (CNS) lymphoma
  • History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
  • Laboratory measures meet the following criteria at screening (unless caused by lymphoma):

Neutrophils<1.5×10^9/L Platelets<75×10^9/L (Neutrophils<1.0×10^9/L, Platelets<50×10^9/L in case of bone marrow involvement) ALT or AST is 2.5 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.

Creatinine is 1.5 times higher than the ULN.

  • HIV-infected patients
  • Active hepatitis infection
  • Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
  • Pregnant or lactation
  • Other medical conditions determined by the researchers that may affect the study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Subgroup 1
TET2/RHOA co-mutated genetic subtype
药品：Azacitidine plus Selinexor with CHOP
Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 for the first cycle. If tumor NGS indicates TP53-mutated genetic subtype, then 1:1 randomized to experimental (CHOPX2) or standard CHOP regimen for 5 cycles of every 28-day cycle. Patients in CHOPX2 group will receive azacitidine d-5 to d-1 and Selinexor 40mg qw combined with standard CHOP.
药品：CHOP
Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 for cycle 1 to cycle 6.
实验性的：Subgroup 2
TP53-mutated genetic subtype
药品：CHOP
Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 for cycle 1 to cycle 6.
药品：Decitabine plus Selinexor with CHOP
Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 for the first cycle. If tumor NGS indicates TP53-mutated genetic subtype, then 1:1 randomized to experimental (CHOPX2) or standard CHOP regimen for 5 cycles of every 28-day cycle. Patients in CHOPX2 group will receive Decitabine RP2D (confrimed by phase I) and Selinexor 40mg qw combined with standard CHOP.
实验性的：Subgroup 3
Core epigenetic genes-mutated genetic subtype
药品：CHOP
Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 for cycle 1 to cycle 6.
药品：Zeprumetostat plus chidamide with CHOP
Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 for the first cycle. If tumor NGS indicates core epigenetic genes-mutated genetic subtype, then 1:1 randomized to experimental (CHOPX2) or standard CHOP regimen for 5 cycles of every 28-day cycle. Patients in CHOPX2 group will receive Zeprumetostat RP2D (confrimed by phase I) and chidamide 20mg biw combined with standard CHOP.
实验性的：Subgroup 4
Other genetic subtype
药品：CHOP
Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 for cycle 1 to cycle 6.
药品：Azacitidine plus Golidocitinib with CHOP
Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 for the first cycle. If tumor NGS indicates other genetic subtype, then 1:1 randomized to experimental (CHOPX2) or standard CHOP regimen for 5 cycles of every 28-day cycle. Patients in CHOPX2 group will receive Azacitidine ih d-5-d-1 and Golidocitinib RP2D (confirmed by Phase I) combined with standard CHOP.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Recommended Phase 2 Dose (RP2D) for Phase I
大体时间：Dose Limiting Toxicity (DLT) time window (28 days from Cycle 2)
: Recommended Phase 2 Dose (RP2D) for Phase I of oral targeted agents in each genetic subtypes by BOIN methods
Dose Limiting Toxicity (DLT) time window (28 days from Cycle 2)
Complete response rate (CRR) for Phase II
大体时间：End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days])
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days])

次要结果测量

结果测量
措施说明
大体时间
CTCAE v5.0 评估的与治疗相关的不良事件的参与者人数
大体时间：从入学到学习完成，最长4年
不良事件是指服用药物的参与者发生的任何不良医学事件，不一定与治疗有因果关系。 因此，不良事件可以是任何不利的和意外的体征（例如，包括异常的实验室发现）、症状或与使用药品暂时相关的疾病，无论是否被认为与药品有关。 在研究期间恶化的既往病症也被视为不良事件。
从入学到学习完成，最长4年
总生存期
大体时间：截至数据截止的基线（最多约 2 年）
总生存期定义为从随机化日期到任何原因死亡日期的时间。
截至数据截止的基线（最多约 2 年）
无进展生存期
大体时间：截至数据截止的基线（最多约 2 年）
无进展生存期定义为从随机化日期到疾病进展或复发的第一个记录日的时间，使用 2014 年卢加诺标准，或任何原因死亡，以先发生者为准。
截至数据截止的基线（最多约 2 年）
Overall response rate (ORR)
大体时间：End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days])
Percentage of participants with complete and partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days])

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ruijin Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2028年1月1日

研究完成 (估计的)

2029年7月1日

研究注册日期

首次提交

2026年7月11日

首先提交符合 QC 标准的

2026年7月11日

首次发布 (实际的)

2026年7月16日

研究记录更新

最后更新发布 (实际的)

2026年7月16日

上次提交的符合 QC 标准的更新

2026年7月11日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • Guidance-08

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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