Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-25 @ 5:49 PM
Study NCT ID:
NCT00337259
Status:
TERMINATED
Last Update Posted:
2016-02-17
First Post:
2006-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemcitabine for Marginal Zone Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}], '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'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'whyStopped': 'poor accrual and response less than expected on interim analysis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-13', 'studyFirstSubmitDate': '2006-06-14', 'studyFirstSubmitQcDate': '2006-06-14', 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'response rate', 'timeFrame': 'CR+PR with study therapy'}], 'secondaryOutcomes': [{'measure': 'safety and tolerability of the treatment', 'timeFrame': 'toxicity due to stdy drug'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['marginal zone lymphoma', 'gemcitabine'], 'conditions': ["Non-Hodgkin's Lymphoma", 'Marginal Zone Lymphoma']}, 'descriptionModule': {'briefSummary': "Marginal zone lymphoma, one of the indolent lymphoma, is believed to be incurable with chemotherapy. Thus the investigators need a novel agent for marginal zone lymphoma. Gemcitabine has been tried as one of salvage chemotherapy regimen and has been shown to have anti-lymphoma activity. To the investigators' knowledge, there has been no trial of gemcitabine for marginal zone lymphoma. Thus the investigators made a plan to investigate the role of gemcitabine in marginal zone lymphoma.", 'detailedDescription': "We designed a multi-center phase II trial of gemcitabine for advanced stage marginal zone B-cell lymphoma. Marginal zone lymphoma needs novel agent to improve clinical course by chemotherapy. Recent trials with new agents for indolent lymphoma shows promising results. Gemcitabine is known to have activity to non-Hodgkin's lymphoma and has less adverse effects than other new agents. With this background gemcitabine will be tried as a single agent for advanced marginal zone lymphoma.\n\nGemcitabine will be administered with 1,250mg/sq.m on days 1 and 8 every 3 weeks. Response will be assessed by IWC criteria."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed marginal zone B-cell lymphoma\n* Performance status (ECOG) ≤3\n* Age ≥ 18\n* At least one or more bidimensionally measurable lesion(s):\n\n * 2 cm by conventional CT\n * 1 cm by spiral CT\n\n * skin lesion (photographs should be taken)\n * measurable lesion by physical examination\n* Laboratory values:\n\n * Cr \\< 2.0 mg% or Ccr \\> 60 ml/min\n * Transaminase \\< 3 X upper normal value\n * Bilirubin \\< 2 mg%\n * ANC \\> 1500/ul, platelet \\> 75,000/ul\n* Informed consent\n* Ann Arbor stage III or IV\n\nExclusion Criteria:\n\n* Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix\n* Serious comorbid diseases\n* Pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT00337259', 'briefTitle': 'Gemcitabine for Marginal Zone Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-cell Lymphoma', 'orgStudyIdInfo': {'id': 'AMC 2006-60'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gemcitabine', 'description': '* histologically confirmed marginal zone lymphoma\n* gemcitabine 1,250 mg/m2 on days 1 and 8 of each cycle, repeated every 3 weeks and continued for 6 cycles, until disease progression, withdrawal due to toxicity, or withdrawal of consent.', 'interventionNames': ['Drug: gemcitabine']}], 'interventions': [{'name': 'gemcitabine', 'type': 'DRUG', 'description': 'D1 and 8, Gemcitabine 1250mg/m2 + NS 100ml MIV over 30min, every 3 weeks', 'armGroupLabels': ['Gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Cheolwon Suh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASCT team', 'investigatorFullName': 'Cheolwon Suh', 'investigatorAffiliation': 'Asan Medical Center'}}}}