Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-01-07 @ 6:24 PM
Study NCT ID:
NCT00302861
Status:
TERMINATED
Last Update Posted:
2008-03-18
First Post:
2006-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'enrollmentInfo': {'count': 86}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-03'}, 'statusVerifiedDate': '2008-03', 'lastUpdateSubmitDate': '2008-03-14', 'studyFirstSubmitDate': '2006-03-13', 'studyFirstSubmitQcDate': '2006-03-13', 'lastUpdatePostDateStruct': {'date': '2008-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients with positive humoral immune responses'}, {'measure': 'Safety and toxicity'}]}, 'conditionsModule': {'keywords': ['B-Cll'], 'conditions': ['B-Cell Chronic Lymphocytic Leukemia']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, open-label, single arm Phase 1/2 study evaluating the feasibility, safety, and tolerability of a series of 16 immunizations of Id-KLH with GM-CSF in patients with previously untreated B-CLL. The length of the controlled portion of the study is two years. The study will be conducted at investigative sites in the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have signed a written informed consent\n* B-CLL diagnosis\n* Rai Stage 0, I, or II\n* Previously untreated\n* Be able to watch and wait for approximately 8 months following submission of blood (or tissue) while Id-KLH is being manufactured\n\nExclusion Criteria:\n\n* Anti-leukemia treatment prior to beginning immunization\n* Anti-leukemia treatment other than Id-KLH during immunizations\n* Prior malignancy (excluding basal cell carcinoma and cervical carcinoma in situ)\n* Pregnant or lactating\n* Patients with known autoimmune disease (including previously treated autoimmune hemolytic anemia or immune thrombocytopenia)\n* Participation in any other clinical trial in which an investigational agent is administered'}, 'identificationModule': {'nctId': 'NCT00302861', 'briefTitle': 'A Study to Evaluate the Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL)', 'nctIdAliases': ['NCT00313651'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Genitope Corporation'}, 'officialTitle': 'Phase 1/2 Study to Evaluate the Feasibility and Tolerability of Treatment of Previously Untreated B-CLL Chronic Lymphocytic Leukemia (B-CLL) Patients With Recombinant Idiotype Conjugated to KLH (Id-KLH) Administered With GM-CSF', 'orgStudyIdInfo': {'id': '2005-11'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MyVax', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Thomas Kipps, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genitope Corporation', 'class': 'INDUSTRY'}}}}