Chemotherapy Effect, Hodgkin Lymphoma
Conditions
Brief summary
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. 1. 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.
Interventions
DRUGTislelizumab
Tislelizumab in first-line treatment of Hodgkin's lymphoma
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with newly diagnosed classical Hodgkin lymphoma (HL) confirmed by histopathology; 2. Stage III-IV, or Stage IIB patients with at least one high-risk factor (NCCN standard) 3. Patients not suitable for receiving radiotherapy subsequently 4. Patients with at least one assessable lesion (according to Lugano 2014 standard); 5. Age 18 or above (including 18), no gender requirement; 6. ECOG PS score of 0-1 points; 7. Expected survival time ≥ 3 months; 8. 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; 9. With normal main indicators of cardio-pulmonary function, and no obvious contraindication to chemotherapy; 10. Not received any anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy, cellular immunotherapy or hematopoietic stem cell transplantation before enrollment; 11. Voluntarily signing an informed consent form before trial screening.
Exclusion criteria
1. Nodular lymphocyte predominant HL; 2. Patients received any form of anti-tumor therapy in the past; 3. Patients planning to receive radiotherapy or autologous stem cell transplantation; 4. With involvement of central nervous system (meninges or brain parenchyma); 5. Pregnant and lactating women and child-bearing patients who are unwilling to take contraceptive measures; 6. Patients with history of other tumors, except for cured cervical cancer orskin basal cell carcinoma; patients who have received organ transplantation; 7. Patients who have received symptomatic treatment of myelosuppressive toxicity within 7 days before enrollment; 8. Patients who have used any immunosuppressive drugs within 4 weeks before the first-dose treatment, 9. Patients with known active interstitial pneumonia; 10. 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; 11. Peripheral neuropathy ≥ Grade 2; 12. 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; 13. Patients with the end-diastolic width of fluid sonolucent area in pericardial cavity ≥10mm by cardiac B-ultrasonography; 14. Mentally disturbed/patients unable to give informed consent; 15. Patients who affect the evaluation of test results due to drug abuse or long-term alcohol abuse; 16. Participating in another interventional clinical study at the same time; Patients not suitable to participate in this trial by the judgment of investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete response rate after two cycles of tislelizumab | 6 weeks | complete response rate after two cycles of tislelizumab by PET/CT |
Countries
China
Outcome results
None listed