Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT00145002
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2005-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study for Aggressive Adult T-cell Leukemia-lymphoma (ATLL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015459', 'term': 'Leukemia-Lymphoma, Adult T-Cell'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D015458', 'term': 'Leukemia, T-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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2004-12'}, 'lastUpdateSubmitDate': '2016-09-20', 'studyFirstSubmitDate': '2005-09-01', 'studyFirstSubmitQcDate': '2005-09-01', 'lastUpdatePostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival'}], 'secondaryOutcomes': [{'measure': 'Toxicity'}, {'measure': 'CR rate'}, {'measure': 'Progression free survival'}]}, 'conditionsModule': {'keywords': ['ATLL', 'chemotherapy', 'phase III study', 'VCAP-AMP-VECP', 'biweekly-CHOP'], 'conditions': ['Adult T-cell Leukemia', 'Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.jcog.jp/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To test the superiority of VCAP-AMP-VECP regimen over biweekly-CHOP in aggressive ATLL in terms of survival benefit.', 'detailedDescription': 'Nothing to describe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of ATL was made based on seropositivity for HTLV-I by either enzyme-linked immunosorbent assay or particle agglutination assay, and histologically- and/or cytologically-proven peripheral T-cell malignancy\n2. Aggressive ATL, i.e., acute-, lymphoma- or unfavorable chronic-type ATL\n3. Aged 15-69 years\n4. No prior chemotherapy or radiotherapy\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3 or 4 as a result of hypercalcemia\n6. Preserved organ (bone marrow, liver, kidney, heart and lung) functions\n7. All patients were required to provide written informed consent\n\nExclusion Criteria:\n\n1. Diabetes mellitus necessitating treatment with insulin\n2. Active systemic infection\n3. Cardiac disorders expected to become worse as a result of the DOX-containing regimen\n4. Acute hepatitis, chronic hepatitis or liver cirrhosis\n5. Positive for HBs Ag or anti-HCV Ab\n6. Active concurrent malignancy\n7. Other serious medical or psychiatric conditions\n8. Pregnancy or breast feeding\n9. Central nervous system involvement by ATL cells'}, 'identificationModule': {'nctId': 'NCT00145002', 'briefTitle': 'A Study for Aggressive Adult T-cell Leukemia-lymphoma (ATLL)', 'organization': {'class': 'OTHER', 'fullName': 'Japan Clinical Oncology Group'}, 'officialTitle': 'Phase III Study of VCAP-AMP-VECP vs. Biweekly CHOP in Aggressive Adult T-cell Leukemia-lymphoma (ATLL): Japan Clinical Oncology Group Study, JCOG9801.', 'orgStudyIdInfo': {'id': 'JCOG9801'}, 'secondaryIdInfos': [{'id': 'C000000066'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis', 'type': 'DRUG'}, {'name': 'biweekly-CHOP with G-CSF and intrathecal prophylaxis', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '852-8523', 'city': 'Nagasaki', 'state': 'Nagasaki', 'country': 'Japan', 'facility': 'Nagasaki University Graduate School of Biomedical Science', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}], 'overallOfficials': [{'name': 'Masao Tomonaga, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nagasaki University Graduate School of Biomedical Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Japan Clinical Oncology Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Labour and Welfare, Japan', 'class': 'OTHER_GOV'}]}}}