NCT05900765

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
2mo left

Started Jun 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jun 2023Jun 2026

First Submitted

Initial submission to the registry

June 2, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

June 14, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

2 years

First QC Date

June 2, 2023

Last Update Submit

June 15, 2023

Conditions

Classical Hodgkin Lymphoma

Keywords

ZimberelimabPD-1 Checkpoint InhibitorAVD

Outcome Measures

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

    Up to approximately 2 months

Secondary Outcomes (7)

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

    Up to approximately 2 years

  • Complete response rate (CRR) after 4 cycles ( Lugano2014)

    Up to approximately 2 years

  • Total ORR and CRR after Zimberelimab treatment + radiotherapy

    Up to approximately 2 years

  • Duration of response (DOR)

    Up to approximately 2 years

  • Progression-free survival time (PFS)

    Up to approximately 2 years

  • +2 more secondary outcomes

Study Arms (1)

Zimberelimab combined with or without AVD sequential radiotherapy

EXPERIMENTAL

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.

Drug: Zimberelimab 240mg

Interventions

Zimberelimab 240mgDRUG

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

Also known as: GLS-010
Zimberelimab combined with or without AVD sequential radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Contraindications to immune checkpoint inhibitors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Oncology, Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

zimberelimab

Study Officials

  • Zhiming Li

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiming Li

CONTACT

+8613719189172lizhm@sysucc.org.cn

Yu Wang

CONTACT

+86-20-87343765wangyu@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 13, 2023

Study Start

June 14, 2023

Primary Completion

June 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)