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

ConditionClassical Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Hodgkin's lymphoma with nodular lymphocyte predominant type.

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

Contraindications to radiotherapy.

With central nervous system (meningeal or parenchymal) involvement.

Trial design

Design model

Single group

Treatments tested in this trial

  • Zimberelimab 240mg

    Drug

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

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: Zimberelimab combined with or without AVD sequential radiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Up to approximately 2 months

Secondary outcomes

1

Objective response rate (ORR) after 4 cycles ( Lugano2014)

ORR is proportion of subjects with complete response(CR) or partial response(PR)

Time frame
Up to approximately 2 years
2

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

Time frame
Up to approximately 2 years
3

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

Time frame
Up to approximately 2 years
4

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

Time frame
Up to approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Guangzhou Gloria Biosciences Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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