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Trial Title:
A Study of Zimberelimab(GLS-010) Combined With AVD for Newly Diagnosed Early-stage Hodgkin's Lymphoma
NCT ID:
NCT05900765
Condition:
Classical Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Hodgkin Disease
Conditions: Keywords:
Zimberelimab
PD-1 Checkpoint Inhibitor
AVD
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Zimberelimab 240mg
Description:
AVD regimen:
Doxorubicin 25mg/m2, d1, d15, IV; Vincristine 3mg/m2, d1, d15 IV; Dacarbazine 0.375mg/m2,
d1, d15 IV
Arm group label:
Zimberelimab combined with or without AVD sequential radiotherapy
Other name:
GLS-010
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiming Li, MD
Phone:
+86-13719189172
Email:
lizhm@sysucc.org.cn
Contact backup:
Last name:
Yu Wang, MD
Phone:
+86-20-87343765
Email:
wangyu@sysucc.org.cn
Start date:
June 14, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Guangzhou Gloria Biosciences Co., Ltd.
Agency class:
Industry
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05900765
