Clinical trial · Interventional
A Study of Zimberelimab(GLS-010) Combined With AVD for Newly Diagnosed Early-stage Hodgkin's Lymphoma
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
NCT05900765CI-TRIAL-00067310unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Classical Hodgkin Lymphoma | Classic Hodgkin Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zimberelimab 240mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zimberelimab combined with or without AVD sequential radiotherapy
- description
- 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.
- interventionNames
- Drug: Zimberelimab 240mg
Primary outcomes (1)
- measure
- Complete response rate (CRR) after 2 cycles
- timeFrame
- Up to approximately 2 months
- description
- 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
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.