Single-arm, Multi-center Clinical Study of PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
To observe the safety, tolerability and clinical effects of PD-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral T-cell lymphoma.
详细描述
Patients with peripheral T-cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional CHOP regimen. The investigators have been proceeding this trial to evaluate the efficacy and safety of the PD-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral T-cell lymphoma.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score≤3;expected survival≥3 months
- •patients with Peripheral T-cell Lymphoma diagnosed by immuno-histochemistry (IHC);
- •acceptable hematological indicators, no chemotherapy contraindications;
- •total bilirubin ≤ 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5 x upper age limit (ULN), if the abnormal laboratory parameters are considered to be caused by lymphoma, patients Eligible conditions should be adjusted to be incorporated into the group;
- •At least one measurable lesion by CT or PET-CT（Positron Emission Tomography-Computed Tomography）;
- •exclude other major diseases, normal heart and lung function;
- •Female patients of childbearing age are negative for pregnancy test;
- •Cooperate with follow-up;
- •There are no other related treatments including traditional Chinese medicine, immunotherapy, and biologic therapy (except for the treatment of anti-bone metastases and other symptoms);
- •Signing informed consent *: Pathological histology must be consulted by a pathologist at a provincial hospital.
排除标准
- •Patients with ALK-positive Anaplastic Large Cell Lymphoma or angioimmunoblastic T-cell lymphoma
- •rejecting providing blood preparation;
- •allergic to drug in this study and with metabolic block;
- •rejecting adopting reliable contraceptive method in pregnancy or lactation period;
- •uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac, lung, liver and pancreas）；
- •with severe infection;
- •with primary or secondary central nervous system tumor invasion;
- •with immunotherapy or radiotherapy contraindication;
- •ever suffered with malignant tumor;
- •having peripheral nervous system disorder or dysphrenia;
- •with no legal capacity,medical or ethical reasons affecting research proceeding;
- •participating other clinical trials simultaneously;
- •adopting other anti-tumor medicine excluding this research;
- •Patients with immunodeficiency, such as primary immunodeficiency syndrome or organ transplant recipients
- •Human immunodeficiency virus (HIV)-positive patients
- •the researchers considering it inappropriate to participate in the study.
- •Patients with immune system diseases
研究组 & 干预措施
Newly diagnosed PTCL
PD-1 Antibody: 200mg, d1, Chidamide: 30mg, twice a week, Lenalidomide: 10mg, d1-10 gemcitabine:600mg/m2, d1 and 21 days made one treatment cycle.
干预措施: PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine (Drug)
Relapse/refractory PTCL
PD-1 Antibody: 200mg, d1, Chidamide: 30mg, twice a week, Lenalidomide: 10mg, d1-10 gemcitabine:600mg/m2, d1 and 21 days made one treatment cycle.
干预措施: PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death
Overall Response Rate
时间窗: From date of randomization until the date tumor volume has reduced, assessed up to 36 months
The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete and partial mitigation.
Overall Survival
时间窗: From date of randomization until date of death from any cause, assessed up to 36 months
Time from randomization to death for any reason
次要结局
未报告次要终点
研究者
Mingzhi Zhang
the director of oncology department of the first affiliated hospital
Zhengzhou University