Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05518318
Status:
UNKNOWN
Last Update Posted:
2022-08-26
First Post:
2022-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GLS-010 Monotherapy Versus Chemotherapy in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma (R/R cHL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719848', 'term': 'zimberelimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2022-08-19', 'studyFirstSubmitQcDate': '2022-08-24', 'lastUpdatePostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of subjects with adverse events (AEs)', 'timeFrame': 'From the time of signed informed consent through 90 days after the last dose of GLS-010', 'description': 'Up to 2 years'}], 'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS) assessed by Independent Radiologic Review Committee (IRRC) per Lugano Classification 2014', 'timeFrame': 'Up to 2 years', 'description': 'Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 2 years', 'description': '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'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to 2 years', 'description': 'ORR defined as the proportion of subjects who achieves a best overall response of CR or PR based on Lugano 2014 classification.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Up to 2 years', 'description': "DCR defined as the proportion of subjects' response of CR, PR, or SD based on Lugano Classification 2014."}, {'measure': 'Duration of Response (DoR)', 'timeFrame': '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', 'description': 'Up to 2 years'}, {'measure': 'Time to Response (TTR)', 'timeFrame': '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', 'description': 'Up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GLS-010', "relapsed or refractory classic Hodgkin's lymphoma"], 'conditions': ["Classic Hodgkin's Lymphoma", 'Recurrent Classic Hodgkin Lymphoma', 'Refractory Classic Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Signed written informed consent form (ICF).\n2. Age of ≥ 18 years at the time of enrollment.\n3. Histologically confirmed classic Hodgkin's lymphoma (cHL).\n4. Subjects required Relapsed or refractory ,failure to at least 2 lines of prior systemic chemotherapy.\n5. Patients who have failed prior vibutuximab treatment or are unwilling or not eligible for vibutuximab treatment\n6. Have at least one measurable lesion according to Lugano classification 2014 and FDG-PET was positive.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. Life expectancy of ≥ 12 weeks.\n9. Have adequate hematologic and organ function .\n\nKey Exclusion Criteria:\n\n1. Nodular lymphocytes are non-Hodgkin's lymphoma or gray area lymphoma.\n2. Central nervous system lymphoma invasion.\n3. Subjects requiring systemic corticosteroids or other immunosuppressive agents within 14 days prior to screening or during the study period.\n4. 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.\n5. Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n6. 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.\n7. 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).\n8. Pregnant or breast-feeding women.\n9. Patients are unsuitable for the study evaluated by investigator."}, 'identificationModule': {'nctId': 'NCT05518318', 'briefTitle': "GLS-010 Monotherapy Versus Chemotherapy in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma (R/R cHL)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangzhou Gloria Biosciences Co., Ltd.'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'GLS-010-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLS-010', 'description': 'GLS-010 therapy', 'interventionNames': ['Drug: GLS-010']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'chemotherapy', 'description': 'chemotherapy', 'interventionNames': ["Drug: Chemotherapy of Investigator's choice"]}], 'interventions': [{'name': 'GLS-010', 'type': 'DRUG', 'otherNames': ['GLS-010 therapy'], 'description': 'Participants receive GLS-010 240mg intravenously (IV) on Day 1, Q2W', 'armGroupLabels': ['GLS-010']}, {'name': "Chemotherapy of Investigator's choice", 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['chemotherapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ting lu', 'role': 'CONTACT', 'email': 'luting_1010@163.com', 'phone': '0086-10-88196391'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Gloria Biosciences Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}