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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-14

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Classical Hodgkin Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Zimberelimab 240mg

Intervention Type DRUG

AVD regimen:

Doxorubicin 25mg/m2, d1, d15, IV; Vincristine 3mg/m2, d1, d15 IV; Dacarbazine 0.375mg/m2, d1, d15 IV

Interventions

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Zimberelimab 240mg

AVD regimen:

Doxorubicin 25mg/m2, d1, d15, IV; Vincristine 3mg/m2, d1, d15 IV; Dacarbazine 0.375mg/m2, d1, d15 IV

Intervention Type DRUG

Other Intervention Names

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GLS-010

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No