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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Hodgkin Lymphoma
- Sponsor
- Sun Yat-sen University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- complete response rate after two cycles of tislelizumab
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
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.
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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;
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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.
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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.
Investigators
Li Zhiming
Professor
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •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;
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
complete response rate after two cycles of tislelizumab
Time Frame: 6 weeks
complete response rate after two cycles of tislelizumab by PET/CT