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| Name | Class |
|---|---|
| Guangzhou Gloria Biosciences Co., Ltd. | INDUSTRY |
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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.
Despite achieving good disease control and long-term survival rates for over 80% of classical Hodgkin lymphoma (cHL) patients who receive first-line therapy, approximately 10% of early-stage and 30% of advanced cHL patients experience disease relapse or refractoriness after initial treatment, and only half of the patients can be cured through high-dose therapy (HDT) and autologous stem cell transplantation (ASCT). Meanwhile, the current standard first-line treatment still centers around conventional chemotherapy with cytotoxic agents. As such, the clinical challenge of cHL first-line treatment lies in striking a balance between efficacy and toxicity, and developing low-toxicity, high-efficiency treatment strategies to achieve the optimal treatment goal of maximizing efficacy while minimizing short- and long-term toxicities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zimberelimab combined with or without AVD sequential radiotherapy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zimberelimab 240mg | Drug | AVD regimen: Doxorubicin 25mg/m2, d1, d15, IV; Vincristine 3mg/m2, d1, d15 IV; Dacarbazine 0.375mg/m2, d1, d15 IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (CRR) after 2 cycles | Percentage of the sum of the number of patients in complete remission (CR), complete remission without confirmation (CRu) to the total number of patients in the full analysis set | Up to approximately 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) after 4 cycles ( Lugano2014) | ORR is proportion of subjects with complete response(CR) or partial response(PR) | Up to approximately 2 years |
| Complete response rate (CRR) after 4 cycles ( Lugano2014) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiming Li | Contact | +8613719189172 | lizhm@sysucc.org.cn | |
| Yu Wang | Contact | +86-20-87343765 | wangyu@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhiming Li | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Oncology, Sun Yat-Sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| C000719848 | zimberelimab |
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Percentage of the sum of the number of patients in complete remission (CR), complete remission without confirmation (CRu) to the total number of patients in the full analysis set
| Up to approximately 2 years |
| Total ORR and CRR after Zimberelimab treatment + radiotherapy | ORR is proportion of subjects with complete response(CR) or partial response(PR); Percentage of the sum of the number of patients in complete remission (CR), complete remission without confirmation (CRu) to the total number of patients in the full analysis set | Up to approximately 2 years |
| Duration of response (DOR) | Duration of response (DoR) is defined as the period from the first documentation of confirmed response (CR or PR) to the first documentation of progressive disease(PD) or death due to any cause, whichever occurs first | Up to approximately 2 years |
| Progression-free survival time (PFS) | Progression-free survival (PFS) is defined as the time from the first dose of investigational products until documentation of PD or death due to any cause, whichever occurs first | Up to approximately 2 years |
| Overall survival (OS) | Overall survival (OS) is defined as the time from the first dose of investigational products until death due to any cause | Up to approximately 2 years |
| Incidence and severity of adverse events(AEs) | Incidence and severity of AEs is aim to evaluate the safety of Zimberelimab(GLS-010) Combined With AVD | Up to approximately 2 years |