Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-01-27 @ 5:31 AM
Study NCT ID:
NCT05660993
Status:
UNKNOWN
Last Update Posted:
2022-12-21
First Post:
2022-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab, Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in Patients With Relapsed/Refractory Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-18', 'releaseDate': '2025-12-04'}], 'estimatedResultsFirstSubmitDate': '2025-12-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2022-12-13', 'studyFirstSubmitQcDate': '2022-12-13', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03 Toxicity parameters based on NCI CTCAE 4.03 grades', 'timeFrame': '12 months'}, {'measure': '2. Overall Response Rate (ORR) Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by LYRIC and Lugano 2014 criteria', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': '1. Duration of Response (DOR)', 'timeFrame': '24 months'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '24 months'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': '24 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PET-adapted Treatment', 'Relapsed/Refractory Hodgkin Lymphoma', 'Nivolumab', 'BeGEV'], 'conditions': ['Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'Nivolumab is an anti-PD-1 antibody highly effective in patients with relapsed/refractory classical Hodgkin lymphoma. A PET-adapted regimen of nivolumab combined with salvage therapy was shown to induce high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, allowing to omit salvage chemotherapy in a substantial proportion of r\\\\r cHL patients. This study evaluates the safety and efficacy of PET-adapted treatment of nivolumab at the 3 mg/kg in combination with Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in patients with relapsed/refractory Hodgkin Lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis: Histologically confirmed Hodgkins lymphoma\n* Relapsed or refractory disease after the first line of treatment\n* Age 18-70 years old\n* Ejection fraction greater than 50%\n* ECOG 0-2 status\n* Signed informed consent\n* No severe concurrent illness\n\nExclusion Criteria:\n\n* Uncontrolled bacterial or fungal infection at the time of enrollment\n* Requirement for vasopressor support at the time of enrollment\n* Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms\n* Karnofsky index \\<30%\n* Pregnancy\n* Somatic or psychiatric disorder making the patient unable to sign an informed consent\n* Active or prior documented autoimmune disease requiring systemic treatment.'}, 'identificationModule': {'nctId': 'NCT05660993', 'briefTitle': 'Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab, Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in Patients With Relapsed/Refractory Hodgkin Lymphoma', 'organization': {'class': 'NETWORK', 'fullName': 'National Research Center for Hematology, Russia'}, 'officialTitle': 'Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab, Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in Patients With Relapsed/Refractory Hodgkin Lymphoma', 'orgStudyIdInfo': {'id': 'r/r cHL-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Main arm', 'description': 'Patients will receive for a maximum of 4 cycles of nivolumab 3 mg/kg on day 0 BeGEV , with subsequent assessment of response by PET-CT. Patients with CR after 2 cycles Nivo-BeGEV will proceed to ASCT.\n\nPatients with \\<CR after 2 cycles of a combination Nivo-BeGEV, with subsequent PET-CT assessment, will receive an additional 2 cycles Nivo-BeGEV. Patients with CR after 4 cycles Nivo-BeGEV will proceed to ASCT.', 'interventionNames': ['Drug: Nivolumab']}], 'interventions': [{'name': 'Nivolumab', 'type': 'DRUG', 'description': 'Drug: Nivolumab Schedule: Nivolumab 3 mg/kg on day 0 of the Nivo-BeGEV or a maximum of 4 cycles Drug: Bendamustine\n\nSchedule:\n\nDay 2: Bendamustine 90mg/mq Day 3: Bendamustine 90mg/mq for a maximum of 4 cycles Other Name: Ribomustin\n\nDrug: Gemcitabine Day 1: Gemcitabine 800mg/mq, Day 4: Gemcitabine 800mg/mq for a maximum of 4 cycles Other Name: Gemzar\n\nDrug: Vinorelbine Day 1 Vinorelbine 20mg/mq for a maximum of 4 cycles Other Name: Navelbine', 'armGroupLabels': ['Main arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '125167', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Elena Parovichnikova', 'role': 'CONTACT', 'email': 'director@blood.ru', 'phone': '7 (495) 612-23-61'}], 'facility': 'National Research Center for Hematology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Yana Mangasarova, MD', 'role': 'CONTACT', 'email': 'v.k.jana@mail.ru', 'phone': '+74956122361'}, {'name': 'Eugene Zvonkov, MD,PhD', 'role': 'CONTACT', 'email': 'dr.zvonkov@mail.ru', 'phone': '+7 (495) 612-13-31'}], 'overallOfficials': [{'name': 'Elena Parovichnikova,, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nathional Medical Research Center for Hematology Moscow Russia 125167'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Research Center for Hematology, Russia', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice-director Nathional Medical Research Center for Hematology Moscow Russia', 'investigatorFullName': 'Elena N.Parovichnikova', 'investigatorAffiliation': 'National Research Center for Hematology, Russia'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-12-04', 'type': 'RELEASE'}, {'date': '2025-12-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'National Research Center for Hematology, Russia'}}}}