Combining Zimberelimab with AVD for 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
PHASE2 · Sun Yat-sen University · NCT05900765
This study is testing if adding a new drug called Zimberelimab to standard chemotherapy can help people with early-stage Hodgkin's lymphoma feel better while causing fewer side effects.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University (other) |
| Drugs / interventions | chemotherapy, Zimberelimab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05900765 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label phase II study aims to evaluate the safety and efficacy of Zimberelimab (GLS-010) in combination with AVD chemotherapy for patients newly diagnosed with early-stage classical Hodgkin lymphoma. The study addresses the challenge of balancing treatment efficacy and toxicity, as current first-line therapies often involve conventional chemotherapy that can lead to significant side effects. By utilizing Zimberelimab, a PD-1 checkpoint inhibitor, the study seeks to develop a treatment strategy that maximizes effectiveness while minimizing both short- and long-term toxicities. Participants will be monitored using PET/CT imaging to assess treatment response.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-45 or over 60 with newly diagnosed classical Hodgkin lymphoma at stage I-II and at least one measurable target lesion.
Not a fit: Patients with nodular lymphocyte predominant Hodgkin's lymphoma or those scheduled for autologous stem cell transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and less toxic treatment option for patients with early-stage Hodgkin's lymphoma.
How similar studies have performed: While the use of PD-1 inhibitors in Hodgkin lymphoma is gaining traction, this specific combination approach is still being evaluated and may represent a novel strategy.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Department of Medical Oncology, Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Principal investigator: Zhiming Li — Sun Yat-sen University
- Study coordinator: Zhiming Li
- Email: lizhm@sysucc.org.cn
- Phone: +8613719189172
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Classical Hodgkin Lymphoma, Zimberelimab, PD-1 Checkpoint Inhibitor, AVD