A Multi-center, Non-randomized, Open-label Phase II Clinical Study on the Treatment of Newly Diagnosed Advanced Hodgkin's Lymphoma With PD-1 Antibody (Tislelizumab) Combined With AVD Regimen (Doxorubicin, Vindesine, Dacarbazine) Under the Guidance of PET/CT
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- complete response rate after two cycles of tislelizumab
研究概览
简要总结
The experimental drug regimen in this study includes a PD-1 antibody (tislelizumab) single-drug induction treatment period and a PD-1 antibody + AVD combined treatment period.
- PD-1 antibody (tislelizumab) single-drug induction treatment period (first 2 courses for all patients + 3-6 courses for CR patients):
PD-1 antibody (tislelizumab), specification: 100mg/bottle. Usage and dosage: intravenous drip, 200mg each time, QD, D1. In the above PD-1 antibody single-drug regimen, 21 days are regarded as a treatment cycle, and all patients first receive 2 courses of PD-1 antibody single-drug induction treatment; 2. PET/CT mid-term efficacy evaluation used for guiding follow-up treatment options:
PET/CT efficacy evaluation before the 3rd course of treatment (PET/CT2):
CR patients: continue to receive PD-1 antibody monotherapy, and then receive 4 courses of PD-1 antibody therapy; PR patients: sequential 4 courses of PD-1 antibody + AVD combined chemotherapy; PD+SD patients: out group, and receive other anti-lymphoma therapy deemed suitable by the investigators;
After the 6th course, patients not out of the group receive PET/CT3 efficacy evaluation:
CR patients: end the treatment and enter the follow-up; PR patients: receive 2 more courses of PD-1 antibody + AVD combined chemotherapy, and then enter the follow-up. 3. PD-1 antibody + AVD combined treatment period (3rd-6th/8th course for PR patients):
PD-1 antibody, specification: 100mg/bottle. Usage and dosage: intravenous drip, 100mg each time, QD, d1, d15. AVD regimen Doxorubicin 25mg/m2, d1, d15 intravenous injection Vindesine 3mg/m2, d1, d15 intravenous injection Dacarbazine 0.375mg/m2, d1, d15 intravenous drip In this combined treatment regimen, every 28 days is a treatment cycle, and the PD-1 antibody is used in combination with AVD in D1 and D15 of each treatment cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed classical Hodgkin lymphoma (HL) confirmed by histopathology;
- •Stage III-IV, or Stage IIB patients with at least one high-risk factor (NCCN standard)
- •Patients not suitable for receiving radiotherapy subsequently
- •Patients with at least one assessable lesion (according to Lugano 2014 standard);
- •Age 18 or above (including 18), no gender requirement;
- •ECOG PS score of 0-1 points;
- •Expected survival time ≥ 3 months;
- •Hematopoietic function: absolute neutrophil count ≥ 1.5×109/L, platelets ≥ 90×109/L, hemoglobin ≥ 90g/L; liver function: for patients with non-hepatitis B, total bilirubin, ALT and AST <1.5×ULN (upper limit of normal); patients with hepatitis B need to take effective antiviral drugs, and HBV-DNA copy <2000 IU/ml and ALT<2×ULN; renal function: creatinine <1.5×ULN and creatinine clearance rate ≥50ml/min;
- •With normal main indicators of cardio-pulmonary function, and no obvious contraindication to chemotherapy;
- •Not received any anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy, cellular immunotherapy or hematopoietic stem cell transplantation before enrollment;
- •Voluntarily signing an informed consent form before trial screening.
排除标准
- •Nodular lymphocyte predominant HL;
- •Patients received any form of anti-tumor therapy in the past;
- •Patients planning to receive radiotherapy or autologous stem cell transplantation;
- •With involvement of central nervous system (meninges or brain parenchyma);
- •Pregnant and lactating women and child-bearing patients who are unwilling to take contraceptive measures;
- •Patients with history of other tumors, except for cured cervical cancer orskin basal cell carcinoma; patients who have received organ transplantation;
- •Patients who have received symptomatic treatment of myelosuppressive toxicity within 7 days before enrollment;
- •Patients who have used any immunosuppressive drugs within 4 weeks before the first-dose treatment,
- •Patients with known active interstitial pneumonia;
- •Abnormal liver function (total bilirubin>1.5×ULN, ALT/AST>2.5×ULN or ALT/AST>5×ULN for patients with liver invasion), abnormal renal function (serum creatinine>1.5×ULN), abnormal electrolyte metabolism;
- •Peripheral neuropathy ≥ Grade 2;
- •Patients with a history of prolonged QT interval which is of clinical significance (male> 450ms, female> 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), patients with symptomatic coronary heart disease requiring drug therapy;
- •Patients with the end-diastolic width of fluid sonolucent area in pericardial cavity ≥10mm by cardiac B-ultrasonography;
- •Mentally disturbed/patients unable to give informed consent;
- •Patients who affect the evaluation of test results due to drug abuse or long-term alcohol abuse;
- •Participating in another interventional clinical study at the same time; Patients not suitable to participate in this trial by the judgment of investigators.
结局指标
主要结局
complete response rate after two cycles of tislelizumab
时间窗: 6 weeks
complete response rate after two cycles of tislelizumab by PET/CT
次要结局
未报告次要终点
研究者
Li Zhiming
Professor
Sun Yat-sen University