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

Hodgkin Lymphoma Clinical Trial

Official title:
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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04843267
Study type	Interventional
Source	Sun Yat-sen University
Contact
Status	Recruiting
Phase	Phase 2
Start date	May 1, 2021
Completion date	May 1, 2025

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