Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-01 @ 9:41 PM
Study NCT ID:
NCT00127569
Status:
TERMINATED
Last Update Posted:
2007-01-12
First Post:
2005-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rituximab in the Treatment of HIV Associated Multicentric Castleman Disease Dependent on Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D005871', 'term': 'Castleman Disease'}, {'id': 'D012514', 'term': 'Sarcoma, Kaposi'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'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': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 25}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2006-01'}, 'lastUpdateSubmitDate': '2007-01-11', 'studyFirstSubmitDate': '2005-08-04', 'studyFirstSubmitQcDate': '2005-08-04', 'lastUpdatePostDateStruct': {'date': '2007-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained response rate of multicentric Castleman disease at day 60, after 4 infusions of rituximab'}], 'secondaryOutcomes': [{'measure': 'One-year disease-free survival'}, {'measure': 'One-year event-free survival'}, {'measure': 'Relapse rate at day 365'}, {'measure': 'One-year lymphoma-free survival'}, {'measure': 'Tolerance of rituximab'}, {'measure': 'One-year overall survival'}, {'measure': 'Change in HHV-8 viral load within one year'}, {'measure': 'Change in lymphocyte B cell count within one year'}]}, 'conditionsModule': {'keywords': ['HIV infections', 'Giant Lymph Node Hyperplasia', 'Herpesvirus 8, Human', 'Rituximab (Mabthera)', 'Antibodies, Monoclonal'], 'conditions': ['HIV Infections', 'Giant Lymph Node Hyperplasia']}, 'descriptionModule': {'briefSummary': 'This trial is aimed to study the efficacy of 4 weekly cycles of rituximab in HIV-infected patients with multicentric Castleman disease (giant lymph node hyperplasia) dependent on chemotherapy. Efficacy is assessed by the complete response rate at day 60. The patients are followed until day 365.', 'detailedDescription': "HIV-related multicentric Castleman disease (MCD) is a lymphoproliferative disorder characterized by lymphadenopathy with angiofollicular hyperplasia and plasma cell infiltration, associated with KSHV/HHV-8. Patients typically have systemic manifestations such as fever associated with lymphadenopathy, hepatosplenomegaly, respiratory symptoms, peripheral edema, cytopenia, hypergammaglobulinemia, hypoalbuminemia, and high levels of serum C reactive protein (CRP). Symptoms correlate with an important increase of KSHV/HHV-8 DNA in peripheral blood mononuclear cells. HIV-MCD is characterized by a rapidly progressive and often fatal course. HIV-MCD is often refractory to treatment. Vinca alkaloids produce frequent but short-lived responses, and most patients remain dependant upon chemotherapy.\n\nLymph nodes of patients with HIV-MCD specifically harbor the virus in B cells located in the mantle zone, which stain positively for the CD20 surface antigen. Rituximab, a humanized monoclonal anti-CD20 antibody, has been reported to be effective in some cases, with conflicting data in other cases. The optimal schedule of infusions remains unclear.\n\nKaposi's sarcoma is often associated with HIV-MCD, and the development of aggressive non-Hodgkin's lymphoma is not a rare outcome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed multicentric Castleman disease, with dependence on vinblastine or VP16 for at least 3 months, whenever they have been splenectomized\n* At least one Castleman crisis since onset of chemotherapy\n* Ongoing highly active antiretroviral therapy (HAART) for at least 3 months\n* No threshold of CD4 cell count and HIV-RNA\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Prior treatment with rituximab\n* Evolutive lymphoma or Kaposi's sarcoma needing treatment\n* Absence of effective contraception\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT00127569', 'briefTitle': 'Rituximab in the Treatment of HIV Associated Multicentric Castleman Disease Dependent on Chemotherapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'French National Agency for Research on AIDS and Viral Hepatitis'}, 'officialTitle': 'Multicenter, Phase II Trial Assessing the Efficacy of Rituximab in HIV Infected Patients With Multicentric Castleman Disease Dependent on Chemotherapy (ANRS 117 Study, CastlemaB)', 'orgStudyIdInfo': {'id': 'ANRS 117 CastlemaB'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rituximab', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Eric Oksenhendler, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AP-HP Hopital Saint-Louis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French National Agency for Research on AIDS and Viral Hepatitis', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}]}}}