A Study of Zimberelimab(GLS-010) Combined With AVD for Newly Diagnosed Early-stage Hodgkin's Lymphoma

Classical Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05900765
• Other study ID #: B2023-134-01
• Status: Recruiting
• Phase: Phase 2
• Start date: June 14, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2023
• Source: Sun Yat-sen University
• Contact: Zhiming Li
• Phone: +8613719189172
• Email: lizhm[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosed with primary classical Hodgkin lymphoma (HL) based on histopathology.

2. Stage I-II .

3. At least one measurable target lesion(Lugano 2014).

4. 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.

5. ECOG PS 0-3,

6. Expected survival = 3 months.

Exclusion Criteria:

1. Hodgkin's lymphoma with nodular lymphocyte predominant type.

2. Patients who are scheduled to undergo subsequent autologous stem cell transplantation.

3. Contraindications to radiotherapy.

4. With central nervous system (meningeal or parenchymal) involvement.

5. Contraindications to immune checkpoint inhibitors.

Related Conditions & MeSH terms

• Classical Hodgkin Lymphoma
• Hodgkin Disease
• Lymphoma

Intervention

Drug:
• Zimberelimab 240mg
AVD regimen: Doxorubicin 25mg/m2, d1, d15, IV; Vincristine 3mg/m2, d1, d15 IV; Dacarbazine 0.375mg/m2, d1, d15 IV

Locations

Country	Name	City	State
China	Department of Medical Oncology, Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Guangzhou Gloria Biosciences Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Complete response rate (CRR) after 4 cycles ( Lugano2014)	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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