Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-02-28 @ 2:49 AM
Study NCT ID:
NCT01311232
Status:
COMPLETED
Last Update Posted:
2017-10-27
First Post:
2011-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Influencing Hepatitis B Virus Reactivation in Lymphoma Patients Treated With Rituximab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2013-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-25', 'studyFirstSubmitDate': '2011-03-06', 'studyFirstSubmitQcDate': '2011-03-06', 'lastUpdatePostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatitis B virus reactivation', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rituximab, lymphoma, hepatitis B virus'], 'conditions': ['Patients With Diffuse Large B-cell Lymphoma or Follicular Lymphoma', 'Patients Treated With Rituximab-CHOP or Rituximab-CVP']}, 'descriptionModule': {'briefSummary': 'This study is a retrospective analysis to identify factors influencing hepatitis B virus reactivation in patients treated with rituximab containing chemotherapy. Rituximab monoclonal antibody targeting CD20 induces B-cell depletion resulting in prolonged immune suppression. This leads to frequent reactivation of patients with a previous history of exposure to HBV or HBV carrier.\n\nWe collect the clinical features and laboratory findings of patients satisfied the inclusion criteria as follows.\n\n1. Patients diagnosed with diffuse large B-cell lymphoma (DLBCL) or \\\\ follicular B-cell lymphoma (FL).\n2. Patients who had received at least two cycles of rituximab-CHOP or rituximab-CVP as a primary treatment\n3. Patients with a history of previous exposure to HBV\n\n * HBV surface antigen (HBs Ag) positive Or\n * HBV core antibody (IgG anti-HBc antibody) positive\n\nThen, we compare the HBV reactivation group with the control group (HBV reactivation does not happen) to find factors influencing HBV reactivation.', 'detailedDescription': 'Description of factors associated with Hepatitis B virus reactivation:\n\n* Laboratory parameters defining HBV status/activity at time of treatment initiation\n* Lymphoma stage at rituximab treatment initiation (Ann Arbor, B-symptoms, bone marrow involvement, IPI, ECOG-score, LDH)\n* Immunochemotherapy regimen (treatment line, rituximab dose and cycle)\n* Disease status at time of HBV reactivation\n* Antiviral prophylaxis (medication, dose, duration at time at time of reactivation)\n* Patient demographics (age, gender, residence, ethnic origin, smoking status, alcohol consumption and occupation)\n\nTime to Hepatitis B virus reactivation\n\n* The time from start of rituximab-containing immunochemotherapy until first evidence of HBV reactivation meeting the criteria\n* Description of prophylaxis and treatment with antiviral medication HBV vaccination Time of initiation of antiviral therapy of prophylaxis relating to clinical or laboratory signs of possible HBV reactivation Anti-viral medication used in prophylaxis or therapy\n* Description of outcomes Outcomes of the HBV reactivation Outcomes of the rituximab-containing immunochemotherapy Demographics and previous infection history: Age, gender, nationality, race, social history, past medical history\n* Parameters associated with lymphomas: Ann Arbor stage, number of extranodal involvement, serum LDH, serum β2-microglobulin, ECOG performance status, presence of B symptoms, International Prognostic Index, bone marrow invasion\n* Laboratory parameters associated with hepatitis B virus:\n\nhepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti- HBs), hepatitis B e antigen (HBeAg), hepatitis B core antibody (anti-HBc), hepatitis B e antibody (anti-HBe), serum HBV DNA\n\n* Lymphoma treatment history:\n\nLine of treatment (first line, second line), rituximab and chemotherapy administration (dose, schedule), start date, last treatment date\n\n* Prophylaxis or treatment against HBV reactivation:\n\nantiviral drug (dose, schedule, duration)\n\n* Hepatitis B virus reactivation:\n\nonset, serologic markers, outcome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hepatitis B virus positivity and treated with rituximab-containing chemotherapy to treat their disease, diffuse large B-cell lymphoma or follicular lymphoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Patients diagnosed with diffuse large B-cell lymphoma (DLBCL) or follicular B-cell lymphoma (FL).\n2. Patients who had received at least two cycles of rituximab-CHOP or rituximab-CVP as a primary treatment\n3. Patients with a history of previous exposure to HBV\n\n * HBV surface antigen (HBs Ag) positive Or\n * HBV core antibody (IgG anti-HBc antibody) positive\n4. Patients with documented HBV reactivation (definite or presumptive) occurring during treatment (at least two cycles of R-CHOP or R-CVP) or within 12 months after the last dose of rituximab\n\n * Definitive HBV reactivation\n\n \\- Elevation of serum HBV DNA level \\>1 log IU/mL from baseline or absolute increase of HBV DNA by 6 log10 IU/mL in HBsAg positive patients\n * Presumptive HBV reactivation - Increase of ALT (≥3x baseline value or absolute value of ≥100 U/L) and positive conversion of HBs Ag in previously HBsAg-negative patients\n\nExclusion Criteria:\n\n1. Patients who had received chemotherapy other than R-CHOP or R-CVP after diagnosis\n2. patients diagnosed with HIV, HCV or HDV co-infection\n3. Patients who had undergone allogenic stem cell transplantation before hepatitis B virus reactivation was documented'}, 'identificationModule': {'nctId': 'NCT01311232', 'briefTitle': 'Factors Influencing Hepatitis B Virus Reactivation in Lymphoma Patients Treated With Rituximab', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Hepatitis B Virus Reactivation in Asian Patients Treated With Rituximab-containing Treatment', 'orgStudyIdInfo': {'id': '2010-11-035'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case', 'description': 'Patients with HBV reactivation'}, {'label': 'Control', 'description': 'Patients without HBV reactivation'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hing Kong', 'country': 'China', 'facility': 'Queen Mary Hospital'}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Hospital Kuala Lumpur', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Won Seog Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}