Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-05 @ 6:15 PM
Study NCT ID:
NCT01678404
Status:
UNKNOWN
Last Update Posted:
2012-09-05
First Post:
2012-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
131I-rituximab for Relapsed or Refractory Marginal Zone B-cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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': 'C507388', 'term': '131I-rituximab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-04', 'studyFirstSubmitDate': '2012-09-04', 'studyFirstSubmitQcDate': '2012-09-04', 'lastUpdatePostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': 'up to 5 years', 'description': 'International Working Group Response criteria'}], 'secondaryOutcomes': [{'measure': 'Response duration', 'timeFrame': 'up to 5 years'}, {'measure': 'Progression free survival', 'timeFrame': 'up to 5 years'}, {'measure': 'Overall survival', 'timeFrame': 'up to 5 years'}, {'measure': 'Number of Adverse Events', 'timeFrame': 'up to 5 years', 'description': 'grading the adverse events using CTCAE version 4.03'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Relapsed or Refractory Marginal Zone B-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'Marginal zone B-cell lymphoma (MZL) is a lymphoma originated from B-cell in lymph node with variable differentiation status, which is distributed to a variety of organs.\n\nA high response rate and long term survival is possible through surgery or radiation therapy alone in the case of limited disease. However frequent relapse and progression is observed despite of long term survival. The treatment after relapse has not been established yet.\n\nSo we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with MZL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed marginal zone B-cell lymphoma\n* relapsed or refractory patients after treatment including chemotherapy, radiation therapy, and surgery\n* Eastern Cooperative Oncology Group performance status ≤ 2\n* age≥ 20 years\n* More than one measurable lesion (More than 2cm sized lesion in conventional CT scan, More than 1cm sized lesion in spiral CT or contrast-enhanced PET/CT )\n* Adequate renal function (serum creatinine ≤ 2.0 mg/dl or Ccr ≥ 60 ml/min)\n* Adequate hepatic function (serum bilirubin ≤ 2.0 mg/dl , AST/ALT ≤ 3 upper normal limit)\n* Adequate bone marrow reservoir (ANC ≥1,500/㎕, platelet count≥ 75,000/㎕)\n* patient who agree the purpose and intention of this clinical trial\n\nExclusion Criteria:\n\n* recent (\\<5 years) history of other malignancy or unrecovered from the disease (appropriately treated skin cancer and uterine cervix carcinoma in situ are excluded)\n* hemodynamically unstable due to the recent (\\<12 months) history of severe heart disease such as myocardial infarction\n* acute complications of severe lung or metabolic disease\n* Combined severe neurological or psychiatric disease\n* Unrecovered from infection or other medical disease\n* Recent (\\<30 days) history of enrollment of other clinical trial\n* Pregnant or breast-feeding woman\n* women of childbearing potential and men not employing adequate contraception at least for 1 year\n* Previous history drug allergy to the content of 131I-rituximab\n* Infection(sepsis, pneumonia, viral infection, etc) (inactivated hepatitis B carrier can be enrolled)'}, 'identificationModule': {'nctId': 'NCT01678404', 'briefTitle': '131I-rituximab for Relapsed or Refractory Marginal Zone B-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Korea Cancer Center Hospital'}, 'officialTitle': 'A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma', 'orgStudyIdInfo': {'id': 'MZL 131I-rituximab RIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '131I-rituximab', 'description': '131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles', 'interventionNames': ['Drug: 131I-rituximab']}], 'interventions': [{'name': '131I-rituximab', 'type': 'DRUG', 'armGroupLabels': ['131I-rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '139-706', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hye Jin Kang, M.D.', 'role': 'CONTACT'}, {'name': 'Dong-Yeop Shin, M.D.', 'role': 'CONTACT'}, {'name': 'Hye Jin Kang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sung Hyun Yang, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Im Il Na, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hyo-Rak Lee, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dong-Yeop Shin, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sang Moo Lim, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Change Woon Choi, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Byung Il Kim, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ilhan Lim, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Seung-Sook Lee, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hye Jin kang, M.D.', 'role': 'CONTACT', 'email': 'mdhyejin@gmail.com', 'phone': '+82-2-970-1289'}, {'name': 'Dong-Yeop Shin, M.D.', 'role': 'CONTACT', 'email': 'baramg@hanmail.net', 'phone': '+82-2-970-1246'}], 'overallOfficials': [{'name': 'Hye Jin Kang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea Cancer Center Hospital', 'class': 'OTHER'}}}}