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临床试验 NCT07493330 针对外周T细胞淋巴瘤，难治性目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Genotype-guided Targeted Agents Plus EZH2i for Primary Refractory PTCL I期, II期 86 联合疗法
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临床试验NCT07493330旨在研究治疗，主要针对外周T细胞淋巴瘤，难治性。这是一项I期 II期 干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年3月23日开始，预计招募86名患者。该研究由Ruijin Hospital主导，计划于2030年12月12日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月25日。
简要概括
To evaluate the safety and efficacy of Zeprumetostat-based combination therapy, selected according to genotyping results, in patients with primary refractory peripheral T-cell lymphoma (PTCL).
详细描述
Peripheral T-cell lymphoma (PTCL) is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for ~10%. Patients with PTCL still have poor treatment response and prognosis under conventional CHOP regimen. Clinical outcomes of refractory patients are even poorer. Targeted drugs are warranted in this group of patients to improve survival. This prospective, multi-center, open-label...显示更多
官方标题
Genotype-guided Targeted Agents in Combination With EZH2 Inhibitor, Zeprumetostat for Primary Refractory Peripheral T-cell Lymphoma (PTCL), a Prospective, Open-label, Multi-center Study
疾病
外周T细胞淋巴瘤难治性其他研究标识符
- Target
NCT编号
实际开始日期
2026-03-23
最近更新发布
2026-03-25
预计完成日期
2030-12-12
计划入组人数
86
研究类型
干预性研究
试验分期 (阶段)
I期
II期
II期
试验状态
尚未招募
关键词
PTCL
Genotype-guided
Zeprumetostat
Refractory
Genotype-guided
Zeprumetostat
Refractory
主要目的
治疗方法
分配方式
非随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Zeprumetostat+Azacitadine (if with TET2 plus RHOA gene mutation) Zeprumetostat: 350 mg bid, orally, till disease progression (PD) or unacceptable toxicity. Azacitadine :100mg D1-D7, subcutaneous injection, should ≥2 out of 6 pts experience a DLT, the dose will be adjusted to: Azacitidine 100 mg D1-D5, subcutaneous injection for total 3 cycles. | Zeprumetostat+Azacitadine Zeprumetostat: 350 mg bid, orally, till disease progression (PD) or unacceptable toxicity. Azacitadine :100mg D1-D7, subcutaneous injection, should ≥2 out of 6 pts experience a DLT, the dose will be adjusted to: Azacitidine 100 mg D1-D5, subcutaneous injection for total 3 cycles. |
实验性Zeprumetostat+Decitabine (if with TP53 gene mutation) Zeprumetostat: 350 mg bid, orally, till disease progression (PD) or unacceptable toxicity. Decitabine 10mg/m2 D1-D5, intravenous infusion, should ≥2 out of 6 pts experience a DLT, the dose will be adjusted to: Decitabine 10mg/m2 D1-D3 for total 3 cycles. | Zeprumetostat+Chidamide Zeprumetostat: 350 mg bid, orally, till disease progression (PD) or unacceptable toxicity. Chidamide 30 mg biw orally, should ≥2 out of 6 pts experience a DLT, the dose will be adjusted to: Chidamide 20 mg biw for total 3 cycles. |
实验性Zeprumetostat+Chidamide (if with CREBBP/EP300/KMT2C/KMT2D/NCOR2 gene mutation) Zeprumetostat: 350 mg bid, orally, till disease progression (PD) or unacceptable toxicity. Chidamide 30 mg biw orally, should ≥2 out of 6 pts experience a DLT, the dose will be adjusted to: Chidamide 20 mg biw for total 3 cycles. | Zeprumetostat+Decitabine Zeprumetostat: 350 mg bid, orally, till disease progression (PD) or unacceptable toxicity. Decitabine 10mg/m2 D1-D5, intravenous infusion, should ≥2 out of 6 pts experience a DLT, the dose will be adjusted to: Decitabine 10mg/m2 D1-D3 for total 3 cycles. |
实验性Zeprumetostat+Golidocitinib (if not above genotype) Zeprumetostat: 350 mg bid, orally, till disease progression (PD) or unacceptable toxicity. Golidocitinib 150 mg qd orally, should ≥2 out of 6 pts experience a DLT, the dose will be adjusted to: Golidocitinib 150 mg qod for total 3 cycles. | Zeprumetostat+Golidocitinib Zeprumetostat: 350 mg bid, orally, till disease progression (PD) or unacceptable toxicity. Golidocitinib 150 mg qd orally, should ≥2 out of 6 pts experience a DLT, the dose will be adjusted to: Golidocitinib 150 mg qod for total 3 cycles. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Summary of DLT events (Phase Ib) | Measure Description: Enroll 6 pts per cohort and observe the number of pts experiencing dose-limiting toxicity. | At the end of Cycle 1 (each cycle is 28 days) |
Overall response rate (Phase Ⅱ) | Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria | At the end of Cycle 3 (each cycle is 28 days) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Complete response rate | Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria | At the end of Cycle 3 |
Disease Control Rate | Percentage of participants with complete response, partial response, or stable disease, as determined by investigator assessment according to the 2014 Lugano criteria, at the end of Cycle 3 | each cycle is 28 days |
Duration of response | Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT. | Baseline up to data cut-off |
Duration of complete response | Time from first occurrence of documented CR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT. | Baseline up to data cut-off |
Progression free survival | Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first. | Baseline up to data cut-off |
Overall survival | Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first. | Baseline up to data cut-off |
Treatment-Related Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Baseline up to data cut-off |
Exploratory biomarker analysis | Exploratory biomarker to predict treatment response and survival e.g. IHC, DNA-seq, etc. | Baseline up to data cut-off |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Age ≥ 18 years, male or female.
- Patients with a histopathologically confirmed diagnosis of peripheral T-cell lymphoma (PTCL) based on 2016 WHO classification
- Previously treated with 3 or 6 cycles of a CHOP-like regimen as first-line therapy and considered primary refractory. Patients with anaplastic large cell lymphoma (ALCL) must have adequately received brentuximab vedotin (BV) as part of their first-line treatment.
- Tumor tissue genotyping performed and results available prior to enrollment.
- ECOG 0, 1, or 2.
- Life expectancy greater than 3 months.
- Adequate organ function
- Contraception during study
- Informed consented
Has a prior malignancy other than the malignancies under study within 3 years without relieve
Primary CNS lymphoma
Known hypersensitivity to any study drug.
Pregnant or lactation
Active infection.
Diseases and medical history:
- Requires continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers
- Has multiple factors affecting oral medication administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- Has a history of psychoactive substance abuse that cannot be discontinued
- Has any severe and/or uncontrolled disease.
Uncontrollable autoimmune disease,
Not able to comply to the protocol for mental or other unknown reasons
Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
Ruijin Hospital研究责任方
Zhao Weili, 主要研究者, Vice president of Ruijin Hospital
研究中心联系人
联系人: Weili Zhao, 086-022-64370045, [email protected]
联系人: Pengpeng Xu, [email protected]
没有位置数据。