Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT00038558
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2002-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prophylactic Use of Filgrastim SD/01 in Patients With Hodgkin's Disease Receiving ABVD Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}], 'ancestors': [{'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': 'C455861', 'term': 'pegfilgrastim'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D001761', 'term': 'Bleomycin'}, {'id': 'D014747', 'term': 'Vinblastine'}, {'id': 'D003606', 'term': 'Dacarbazine'}], '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'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-30', 'studyFirstSubmitDate': '2002-05-31', 'studyFirstSubmitQcDate': '2002-05-31', 'lastUpdatePostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2002-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients with Response to Prophylactic Filgrastim SD/01Chemotherapy', 'timeFrame': 'Following ABVD chemotherapy course'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Hodgkin's lymphoma", 'Dacarbazine', 'DTIC', 'DTIC-Dome', 'Vinblastine', 'Velban', 'Bleomycin sulfate', 'Blenoxane', 'BLM', 'Doxorubicin Hydrochloride', 'Adriamycin', 'Filgrastim', 'G-CSF', 'Neupogen', 'Pegfilgrastim', 'granulocyte colony-stimulating factor'], 'conditions': ['Hodgkin Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'UT MD Anderson Cancer Center website'}]}, 'descriptionModule': {'briefSummary': "Prophylactic use of Filgrastim SD/01 for patients with Hodgkin's lymphoma receiving ABVD chemotherapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION:\n\n* Previously untreated Hodgkin's disease patients who are scheduled to receive standard ABVD chemo.\n* Histologically proven diagnosis of Hodgkin's disease of any type.\n* Bidimensionally measurable disease.\n* Signed informed consent.\n* Age \\>/= 16 yrs.\n* Adequate bone marrow reserve (ANC\\>1000/uL, Platelet \\>100,000/uL.\n* LVEF\\>/=50% by MUGA scan or echocardiogram.\n* Serum creatinine \\<2mg/dL; serum bilirubin\\<2mg/dL.\n\nEXCLUSION:\n\n* HIV positive.\n* Pregnant women and those of child bearing age who are not using adequate contraception.\n* Prior chemotherapy.\n* Severe pulmonary disease including COPD and asthma.\n* History of prior sensitivity to E.coli derived products."}, 'identificationModule': {'nctId': 'NCT00038558', 'briefTitle': "Prophylactic Use of Filgrastim SD/01 in Patients With Hodgkin's Disease Receiving ABVD Chemotherapy", 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': "Prophylactic Use of Filgrastim SD/01 In Patients With Hodgkin's Disease Receiving ABVD Chemotherapy", 'orgStudyIdInfo': {'id': 'ID01-087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Filgrastim + ABVD Chemotherapy', 'interventionNames': ['Drug: Filgrastim SD/01', 'Drug: Adriamycin', 'Drug: Bleomycin', 'Drug: Vinblastine', 'Drug: DTIC']}], 'interventions': [{'name': 'Filgrastim SD/01', 'type': 'DRUG', 'otherNames': ['G-CSF', 'Neupogen'], 'armGroupLabels': ['Filgrastim + ABVD Chemotherapy']}, {'name': 'Adriamycin', 'type': 'DRUG', 'otherNames': ['Doxorubicin Hydrochloride', 'Adriamycin PFS', 'Adriamycin RDF'], 'armGroupLabels': ['Filgrastim + ABVD Chemotherapy']}, {'name': 'Bleomycin', 'type': 'DRUG', 'otherNames': ['Bleomycin sulfate', 'Blenoxane', 'BLM'], 'armGroupLabels': ['Filgrastim + ABVD Chemotherapy']}, {'name': 'Vinblastine', 'type': 'DRUG', 'otherNames': ['Velban'], 'armGroupLabels': ['Filgrastim + ABVD Chemotherapy']}, {'name': 'DTIC', 'type': 'DRUG', 'otherNames': ['DTIC-Dome', 'Dacarbazine'], 'armGroupLabels': ['Filgrastim + ABVD Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Anas Younes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT MD Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}