Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-30 @ 8:30 PM
Study NCT ID:
NCT00428233
Status:
COMPLETED
Last Update Posted:
2020-04-08
First Post:
2007-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-06', 'studyFirstSubmitDate': '2007-01-25', 'studyFirstSubmitQcDate': '2007-01-25', 'lastUpdatePostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To collect up to 20 patient samples per year that could potentially be used to prepare autologous tumor cell vaccines.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CLL', 'vaccine'], 'conditions': ['Chronic Lymphocytic Leukemia']}, 'descriptionModule': {'briefSummary': "The purpose of this research study is to collect, freeze and store leukemia cells from the blood or bone marrow of patients that have advanced chronic lymphocytic leukemia (CLL) that is not in clinical remission. This study is a companion study to DF/HCC clinical trial 06-196 in which the participants' own CLL cells may form part of a vaccine treatment for their leukemia.", 'detailedDescription': '* It is important to understand that even if the participant consents to allow us to save their leukemia cells, we cannot guarantee that they will be able to receive a vaccine. First, we may not be able to make enough vaccine from the collected cells. Second, they may not be able to participate in a vaccine study in the future for reasons related to the status of your overall health. Third, an appropriate vaccine trial may not be available in the future.\n* In order to make the vaccine, leukemia cells will be collected by one or more of the following methods: drawing blood during one of two visits to the clinic; leukapheresis; bone marrow aspiration; or, surgery to remove a lymph node.\n* The physician will discuss with the participant which approach is best in their case to ensure the highest number of tumor cells collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to harvest CLL cells from peripheral blood, lymph nodes or bone marrow, defined as \\> 30% involvement of bone marrow intratrabecular space, or peripheral blood lymphocytosis \\> 5000/microliter, or surgically accessible lymph nodes of greater than or equal to 2cm.\n* ECOG performance status 0-2\n* 18 years of age or older\n\nExclusion Criteria:\n\n* Uncontrolled infection\n* Leukemia with active CNS involvement'}, 'identificationModule': {'nctId': 'NCT00428233', 'briefTitle': 'Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation', 'orgStudyIdInfo': {'id': '06-200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Leukemia Cell Harvest', 'description': 'Procedure/Surgery: Leukemia cell harvest Leukemia cells will be harvested either by: Blood draw, leukapheresis, bone marrow aspiration or surgery to remove the lymph node', 'interventionNames': ['Procedure: Leukemia cell harvest']}], 'interventions': [{'name': 'Leukemia cell harvest', 'type': 'PROCEDURE', 'description': 'Leukemia cells will be harvested either by: Blood draw, leukapheresis, bone marrow aspiration or surgery to remove the lymph node', 'armGroupLabels': ['Leukemia Cell Harvest']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Catherine J. Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Catherine Wu, MD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}