Classical Hodgkin LymphomaPhase 2NCT05900765
A Study of Zimberelimab(GLS-010) Combined With AVD for Newly Diagnosed Early-stage Hodgkin's Lymphoma
A Phase 2 study testing Zimberelimab 240mg in people with Classical Hodgkin Lymphoma, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Classical Hodgkin Lymphoma
- What is being tested?
- Zimberelimab 240mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2023to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhiming Li, MD, +86-13719189172, lizhm@sysucc.org.cn
Yu Wang, MD, +86-20-87343765, wangyu@sysucc.org.cn
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Classical Hodgkin Lymphoma
- Being tested
- Zimberelimab 240mg
- Keywords
- Zimberelimab, PD-1 Checkpoint Inhibitor, AVD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zimberelimab 240mgDrug
Also called GLS-010
AVD regimen:
Doxorubicin 25mg/m2, d1, d15, IV; Vincristine 3mg/m2, d1, d15 IV; Dacarbazine 0.375mg/m2, d1, d15 IV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Zimberelimab 240mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to approximately 2 months
Secondary outcomes (7)
Objective response rate (ORR) after 4 cycles ( Lugano2014)
ORR is proportion of subjects with complete response(CR) or partial response(PR)
Measured: Up to approximately 2 years
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
Measured: Up to approximately 2 years
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
Measured: Up to approximately 2 years
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
Measured: Up to approximately 2 years
Progression-free survival time (PFS)
Progression-free survival (PFS) is defined as the time from the first dose of investigational products until documentation of PD or death due to any cause, whichever occurs first
Measured: Up to approximately 2 years
Overall survival (OS)
Overall survival (OS) is defined as the time from the first dose of investigational products until death due to any cause
Measured: Up to approximately 2 years
Incidence and severity of adverse events(AEs)
Incidence and severity of AEs is aim to evaluate the safety of Zimberelimab(GLS-010) Combined With AVD
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start14 Jun 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classical Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Gloria Biosciences Co., Ltd.
- Responsible party
- Principal investigator, Li Zhiming, Sun Yat-sen University
- Investigators
- Zhiming Li, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900765
- Sponsor's protocol ID
- B2023-134-01
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05900765
- Acronym / sponsor ID
- B2023-134-01
- Conditions
- Classical Hodgkin Lymphoma
- Keywords
- Zimberelimab, PD-1 Checkpoint Inhibitor, AVD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangzhou Gloria Biosciences Co., Ltd.
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zimberelimab combined with or without AVD sequential radiotherapy | Experimental | Drug: Zimberelimab 240mg1. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zimberelimab 240mgAlso: GLS-010AVD regimen: Doxorubicin 25mg/m2, d1, d15, IV; Vincristine 3mg/m2, d1, d15 IV; Dacarbazine 0.375mg/m2, d1, d15 IV | Drug | Zimberelimab combined with or without AVD sequential radiotherapy |
Primary outcome
Complete response rate (CRR) after 2 cycles
Time frame: Up to approximately 2 months
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
7 secondary outcomes
Objective response rate (ORR) after 4 cycles ( Lugano2014)
Time frame: Up to approximately 2 years
Complete response rate (CRR) after 4 cycles ( Lugano2014)
Time frame: Up to approximately 2 years
Total ORR and CRR after Zimberelimab treatment + radiotherapy
Time frame: Up to approximately 2 years
Duration of response (DOR)
Time frame: Up to approximately 2 years
Progression-free survival time (PFS)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Incidence and severity of adverse events(AEs)
Time frame: Up to approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiming Li principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zimberelimab 240mg in people with Classical Hodgkin Lymphoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiming Li (+8613719189172, lizhm@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (CRR) after 2 cycles (time frame: Up to approximately 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.