Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-01-01 @ 1:22 PM
Study NCT ID:
NCT01676558
Status:
UNKNOWN
Last Update Posted:
2012-11-14
First Post:
2012-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study of 131I-rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], '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': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-11-13', 'studyFirstSubmitDate': '2012-08-24', 'studyFirstSubmitQcDate': '2012-08-30', 'lastUpdatePostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', '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 event', 'timeFrame': 'up to 5 years', 'description': 'grading the adverse events using CTCAE version 4.03'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diffuse large B cell lymphoma', 'radioimmunotherapy', '131I-rituximab'], 'conditions': ['Relapsed or Refractory Diffuse Large B Cell Lymphoma']}, 'descriptionModule': {'briefSummary': "Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma in Korea. Although there is standard therapy, which is called 'R-CHOP', many obstacles to use aggressive cytotoxic chemotherapeutic agents such as old age, poor performance status, refractoriness, and relapsed disease still remains. So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with DLBCL."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed diffuse large B cell lymphoma Elderly (\\>65 years) or medically ineligible to standard cytotoxic chemotherapy due to poor performance status, or relapsed or refractory patients Eastern Cooperative Oncology Group performance status ≤ 2, age≥ 20 years Relapsed or refractory after autologous hematopoietic stem cell transplantation (auto-HSCT) in young patients with good performance status and indicated to high dose chemotherapy and auto-HSCT More than one measurable lesion\n* More than 2cm sized lesion in conventional CT scan,\n* More than 1cm sized lesion in spiral CT or contrast-enhanced PET/CT Adequate renal function (serum creatinine ≤ 2.0 mg/dl or Ccr ≥ 60 ml/min) Adequate hepatic function (serum bilirubin ≤ 2.0 mg/dl , AST/ALT ≤ 3 upper normal limit) Adequate bone marrow reservoir (ANC ≥1,500/㎕, platelet count≥ 75,000/㎕) 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\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 Unrecovered from infection or other medical disease Recent (\\<30 days) history of enrollment of other clinical trial Pregnant or breast-feeding woman women of childbearing potential and men not employing adequate contraception at least for 1 year Previous history drug allergy to the content of 131I-rituximab Infection(sepsis, pneumonia, viral infection, etc) (inactivated hepatitis B carrier can be enrolled) Young patient with good performance status indicated to autologous hematopoietic stem cell transplantation irrespective of the failure of 1st line chemotherapy'}, 'identificationModule': {'nctId': 'NCT01676558', 'briefTitle': 'A Phase II Study of 131I-rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)', 'organization': {'class': 'OTHER', 'fullName': 'Korea Cancer Center Hospital'}, 'officialTitle': 'A Phase II Study of 131I-rituximab for Elderly or Poor Performance Status Patients With Diffuse Large B Cell Lymphoma (DLBCL) or for Adult Patients With Relapsed or Refractory DLBCL', 'orgStudyIdInfo': {'id': 'DLBCL_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', 'facility': 'Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'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': 'Dong-Yeop Shin, M.D.', 'role': 'SUB_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': 'Sang Moo Lim, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chang Woon Choi, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Byung Il Kim, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ilhan Im, 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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea Cancer Center Hospital', 'class': 'OTHER'}}}}