A Multicenter, Open-label Phase II Study on the Treatment of Newly Diagnosed Early-stage Hodgkin's Lymphoma With Zimberelimab (GLS-010) Combined With AVD Regimen (Doxorubicin, Vindesine, Dacarbazine) Under the Guidance of PET/CT
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a multicenter, open-label single-arm phase II study to evaluate the efficacy and safety of Zimberelimab (GLS-010) combined with AVD for newly diagnosed early-stage Hodgkin's lymphoma under the guidance of PET/CT.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosed with primary classical Hodgkin lymphoma (HL) based on histopathology.
• Stage I-II .
• At least one measurable target lesion（Lugano 2014）.
• Age 18 years or older (including 18 years) to 45 years (recent fertility requirements and concern about chemotherapy side effects), or age \>60 years (older patients who are frail and unwilling to undergo chemotherapy), male or female.
• ECOG PS 0-3,
• Expected survival ≥ 3 months.
Locations
Other Locations
China
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Zhiming Li
lizhm@sysucc.org.cn
+8613719189172
Backup
Yu Wang
wangyu@sysucc.org.cn
+86-20-87343765
Time Frame
Start Date: 2023-06-14
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 54
Treatments
Experimental: Zimberelimab combined with or without AVD sequential radiotherapy
1. Combination therapy： Subjects received Zimberelimab 240mg Q3W 2 cycle.~ According to the results of PET/CT evaluation:~ CR: Additional 2 cycles of Zimberelimab (4 cycles of Zimberelimab monotherapy in total); PR: 2 cycles of Zimberelimab+ AVD therapy (only PR patients combined with AVD). Subjects who did not achieve a Partial Response (PR) or Complete Response (CR) in their initial or subsequent efficacy evaluations, and whose potential for benefit was deemed unlikely by the investigator, were discontinued from the study.~2. Radiotherapy treatment period (patients with CR/PR): Sequentially radiation therapy 20-30Gy.
Related Therapeutic Areas
Sponsors
Collaborators: Guangzhou Gloria Biosciences Co., Ltd.
Leads: Sun Yat-sen University