Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-02 @ 12:57 PM
Study NCT ID:
NCT02843061
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2016-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Rituximab and NK Immunotherapy for B Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2016-07-21', 'studyFirstSubmitQcDate': '2016-07-22', 'lastUpdatePostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relief degree evaluated by the RECIST', 'timeFrame': '3 months', 'description': 'It will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)'}], 'secondaryOutcomes': [{'measure': 'Progress free survival (PFS)', 'timeFrame': '1 year'}, {'measure': 'Overall survival (OS)', 'timeFrame': '3 years'}]}, 'conditionsModule': {'keywords': ['B lymphoma', 'Rituximab', 'NK immunotherapy'], 'conditions': ['B-cell Lymphoma Recurrent']}, 'descriptionModule': {'briefSummary': 'The aim of this study is the safety and efficacy of Rituximab plus NK immunotherapy to recurrent B lymphoma.', 'detailedDescription': 'By enrolling patients with B lymphoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using Rituximab and natural killer (NK) cells.\n\nThe safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence\n* Body tumor 1-6, the maximum tumor length \\< 5 cm\n* KPS ≥ 70, lifespan \\> 6 months\n* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L\n\nExclusion Criteria:\n\n* Patients with cardiac pacemaker\n* Patients with brain metastasis\n* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction'}, 'identificationModule': {'nctId': 'NCT02843061', 'briefTitle': 'Combination of Rituximab and NK Immunotherapy for B Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Fuda Cancer Hospital, Guangzhou'}, 'orgStudyIdInfo': {'id': 'NK-Rituximab'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rituximab and NK immunotherapy', 'description': 'In this group, the patients will receive regular Rituximab treatment accompanied with multiple NK immunotherapy. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).', 'interventionNames': ['Drug: Rituximab', 'Biological: NK immunotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rituximab', 'description': 'In this group, the patients will receive regular Rituximab to decrease tumor burden. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).', 'interventionNames': ['Drug: Rituximab']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['IDEC-C2B8 or Rituxan'], 'armGroupLabels': ['Rituximab', 'Rituximab and NK immunotherapy']}, {'name': 'NK immunotherapy', 'type': 'BIOLOGICAL', 'otherNames': ['natural killer cell'], 'description': 'Each time 10 billion cells, 4 times in all,i.v.', 'armGroupLabels': ['Rituximab and NK immunotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510665', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Cancer Institute in Fuda cancer hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Jibing Chen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fuda Cancer Hospital, Guangzhou'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuda Cancer Hospital, Guangzhou', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shenzhen Hank Bioengineering Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}