Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT00031902
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2002-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'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': 'D001761', 'term': 'Bleomycin'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-02', 'lastUpdateSubmitDate': '2013-09-19', 'studyFirstSubmitDate': '2002-03-08', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['AIDS-related peripheral/systemic lymphoma', 'AIDS-related diffuse large cell lymphoma', 'AIDS-related immunoblastic large cell lymphoma', 'AIDS-related small noncleaved cell lymphoma', 'AIDS-related diffuse mixed cell lymphoma', 'AIDS-related diffuse small cleaved cell lymphoma', 'AIDS-related lymphoblastic lymphoma'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with chemotherapy may kill more cancer cells.\n\nPURPOSE: Phase I trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\n* Determine the response rate of patients with poor-prognosis, HIV-related non-Hodgkin's lymphoma treated with rituximab combined with prednisolone, vincristine, and bleomycin.\n* Determine the toxicity of this regimen in these patients.\n* Determine the time to progression and survival of patients treated with this regimen.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive chemotherapy comprising vincristine IV and bleomycin IV on day 1 and oral prednisolone every other day beginning on day 1. Treatment repeats every 3 weeks for 6 courses. Patients also receive rituximab on days 14, 21, 28, and 35. Patients who achieve complete response (CR) receive 2 additional courses of chemotherapy after CR.\n\nPatients are followed every 1-2 months.\n\nPROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Diagnosis of poor-prognosis, HIV-related non-Hodgkin's lymphoma (HIV-NHL)\n\n * Previously untreated\n* More than 1 of the following criteria:\n\n * Prior diagnosis of AIDS\n * ECOG performance status 3-4\n * CD4 count less than 100/mm3\n* No primary cerebral lymphoma\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* See Disease Characteristics\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No prior chemotherapy for HIV-NHL\n* At least 1 year since prior chemotherapy for Kaposi's sarcoma (KS)\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Prior radiotherapy for HIV-NHL allowed\n* At least 1 year since prior radiotherapy for KS\n\nSurgery:\n\n* Not specified"}, 'identificationModule': {'nctId': 'NCT00031902', 'briefTitle': "Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma", 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': "Rituxumab Combined With Chemotherapy (PVB) For Poor Prognosis HIV-Related Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'CDR0000069238'}, 'secondaryIdInfos': [{'id': 'BNLI-POORRISKHIV'}, {'id': 'EU-20145'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'bleomycin sulfate', 'type': 'BIOLOGICAL'}, {'name': 'rituximab', 'type': 'BIOLOGICAL'}, {'name': 'prednisolone', 'type': 'DRUG'}, {'name': 'vincristine sulfate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW17 0QT', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "St. George's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW10 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Chelsea Westminster Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Ruth Pettengell, MD', 'role': 'STUDY_CHAIR', 'affiliation': "St. George's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lymphoma Trials Office', 'class': 'OTHER'}}}}