Classic Hodgkin's LymphomaPhase 3NCT05518318
GLS-010 Monotherapy Versus Chemotherapy in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma (R/R cHL)
A Phase 3 study testing GLS-010 and Chemotherapy of Investigator's choice in people with Classic Hodgkin's Lymphoma and Recurrent Classic Hodgkin Lymphoma, run by Guangzhou Gloria Biosciences Co., Ltd..
Trial summary
The primary objective of this study is to evaluate the efficacy of GLS-010 in participants with relapsed or refractory classical Hodgkin lymphoma (R/R cHL), as measured by Progression-free Survival (PFS) as assessed by IRRC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Classic Hodgkin's Lymphoma, Recurrent Classic Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma
- What is being tested?
- GLS-010 and Chemotherapy of Investigator's choice
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Jun 2025
- Phase
- Phase 3
- 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
- Signed written informed consent form (ICF).
- Age of ≥ 18 years at the time of enrollment.
- Histologically confirmed classic Hodgkin's lymphoma (cHL).
- Subjects required Relapsed or refractory ,failure to at least 2 lines of prior systemic chemotherapy.
- Patients who have failed prior vibutuximab treatment or are unwilling or not eligible for vibutuximab treatment
- Have at least one measurable lesion according to Lugano classification 2014 and FDG-PET was positive.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥ 12 weeks.
- Have adequate hematologic and organ function .
Who cannot join
- Nodular lymphocytes are non-Hodgkin's lymphoma or gray area lymphoma.
- Central nervous system lymphoma invasion.
- Subjects requiring systemic corticosteroids or other immunosuppressive agents within 14 days prior to screening or during the study period.
- Prior exposure to any anti-PD-1, anti-PD-L1,anti-PD-L2, anti-CD137,anti-CTLA-4 antibody, or any other antibody or drug target for T cell co-stimulatory or checkpoint pathways.
- Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Subjects with other malignancy within 5 years prior to the first dose of study treatment, except for Cervical carcinoma in situ and Cured basal cell carcinoma of the skin.
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- Have received chemotherapy, radiotherapy, molecular-targeted therapy or major surgery within 4 weeks prior to the first dose of study treatmen; Clinically significant AE associated with previous treatment has not returned to baseline or ≤1 (except hair loss).
- Pregnant or breast-feeding women.
- Patients are unsuitable for the study evaluated by investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluate the Efficacy and Safety of GLS-010 Versus Chemotherapy Assessed by Investigator in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma (R/R cHL) in a Randomized, Open, Multicenter Phase III Trial
The primary objective of this study is to evaluate the efficacy of GLS-010 in participants with relapsed or refractory classical Hodgkin lymphoma (R/R cHL), as measured by Progression-free Survival (PFS) as assessed by IRRC
- Conditions
- Classic Hodgkin's Lymphoma, Recurrent Classic Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma
- Being tested
- GLS-010, Chemotherapy of Investigator's choice
- Keywords
- GLS-010, relapsed or refractory classic Hodgkin's lymphoma
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLS-010Drug
Also called GLS-010 therapy
Participants receive GLS-010 240mg intravenously (IV) on Day 1, Q2W
Chemotherapy of Investigator's choiceDrug
Chemotherapy administered as assessed as appropriate by the investigator in accordance with the local guideline, including but not limited to DHAP,GEMOX, ESHAP , ICE , IGEV and GVD
| Study group | Role | What they receive |
|---|---|---|
| GLS-010 | Experimental | GLS-010 therapy Receives: Drug: GLS-010 |
| chemotherapy | Active comparator | chemotherapy Receives: Drug: Chemotherapy of Investigator's choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) assessed by Independent Radiologic Review Committee (IRRC) per Lugano Classification 2014
Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.
Measured: Up to 2 years
Secondary outcomes (5)
Overall Survival (OS)
Defined as the time from the date of randomization to the date of death due to any Defined as the time from the date of randomization to the date of death due to any reason
Measured: Up to 2 years
Objective Response Rate (ORR)
ORR defined as the proportion of subjects who achieves a best overall response of CR or PR based on Lugano 2014 classification.
Measured: Up to 2 years
Disease Control Rate (DCR)
DCR defined as the proportion of subjects' response of CR, PR, or SD based on Lugano Classification 2014.
Measured: Up to 2 years
Duration of Response (DoR)
Up to 2 years
Measured: DoR defined as the time from the date that CR or PR are first occurred to the date of objective disease progression or death, whichever occurs first
Time to Response (TTR)
Up to 2 years
Measured: TTR defined as the time from the date of randomization to the date when the response criteria are first met, based on Lugano Classification 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classic Hodgkin's LymphomaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Gloria Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518318
- Sponsor's protocol ID
- GLS-010-31
- Status last verified
- Aug 2022
- First submitted
- 19 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy and Safety of GLS-010 Versus Chemotherapy Assessed by Investigator in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma (R/R cHL) in a Randomized, Open, Multicenter Phase III Trial
- ClinicalTrials.gov ID
- NCT05518318
- Acronym / sponsor ID
- GLS-010-31
- Conditions
- Classic Hodgkin's Lymphoma, Recurrent Classic Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma
- Keywords
- GLS-010, relapsed or refractory classic Hodgkin's lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangzhou Gloria Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2022 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 26 Aug 2022 (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.
The primary objective of this study is to evaluate the efficacy of GLS-010 in participants with relapsed or refractory classical Hodgkin lymphoma (R/R cHL), as measured by Progression-free Survival (PFS) as assessed by IRRC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLS-010 | Experimental | Drug: GLS-010GLS-010 therapy |
| chemotherapy | Active comparator | Drug: Chemotherapy of Investigator's choicechemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed written informed consent form (ICF).
- Age of ≥ 18 years at the time of enrollment.
- Histologically confirmed classic Hodgkin's lymphoma (cHL).
- Subjects required Relapsed or refractory ,failure to at least 2 lines of prior systemic chemotherapy.
- Patients who have failed prior vibutuximab treatment or are unwilling or not eligible for vibutuximab treatment
Key exclusion criteria (9 listed)
- Nodular lymphocytes are non-Hodgkin's lymphoma or gray area lymphoma.
- Central nervous system lymphoma invasion.
- Subjects requiring systemic corticosteroids or other immunosuppressive agents within 14 days prior to screening or during the study period.
- Prior exposure to any anti-PD-1, anti-PD-L1,anti-PD-L2, anti-CD137,anti-CTLA-4 antibody, or any other antibody or drug target for T cell co-stimulatory or checkpoint pathways.
- Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
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 |
|---|---|---|
| GLS-010Also: GLS-010 therapyParticipants receive GLS-010 240mg intravenously (IV) on Day 1, Q2W | Drug | GLS-010 |
| Chemotherapy of Investigator's choiceChemotherapy administered as assessed as appropriate by the investigator in accordance with the local guideline, including but not limited to DHAP,GEMOX, ESHAP , ICE , IGEV and GVD | Drug | chemotherapy |
Primary outcome
Progression Free Survival (PFS) assessed by Independent Radiologic Review Committee (IRRC) per Lugano Classification 2014
Time frame: Up to 2 years
Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.
5 secondary outcomes
Overall Survival (OS)
Time frame: Up to 2 years
Objective Response Rate (ORR)
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
Duration of Response (DoR)
Time frame: DoR defined as the time from the date that CR or PR are first occurred to the date of objective disease progression or death, whichever occurs first
Time to Response (TTR)
Time frame: TTR defined as the time from the date of randomization to the date when the response criteria are first met, based on Lugano Classification 2014
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GLS-010 and Chemotherapy of Investigator's choice in people with Classic Hodgkin's Lymphoma and Recurrent Classic Hodgkin Lymphoma, run by Guangzhou Gloria Biosciences Co., Ltd..
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 9 inclusion and 9 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 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 ting lu (0086-10-88196391, luting_1010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) assessed by Independent Radiologic Review Committee (IRRC) per Lugano Classification 2014 (time frame: Up to 2 years). 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 26 Aug 2022.