Rituximab in the Treatment of HIV Associated Multicentric Castleman Disease Dependent on Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00127569|
Recruitment Status : Terminated
First Posted : August 8, 2005
Last Update Posted : January 12, 2007
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Giant Lymph Node Hyperplasia||Drug: Rituximab||Phase 2|
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.
Lymph 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.
Kaposi's sarcoma is often associated with HIV-MCD, and the development of aggressive non-Hodgkin's lymphoma is not a rare outcome.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Phase II Trial Assessing the Efficacy of Rituximab in HIV Infected Patients With Multicentric Castleman Disease Dependent on Chemotherapy (ANRS 117 Study, CastlemaB)|
|Study Start Date :||May 2003|
|Study Completion Date :||January 2006|
- Sustained response rate of multicentric Castleman disease at day 60, after 4 infusions of rituximab
- One-year disease-free survival
- One-year event-free survival
- Relapse rate at day 365
- One-year lymphoma-free survival
- Tolerance of rituximab
- One-year overall survival
- Change in HHV-8 viral load within one year
- Change in lymphocyte B cell count within one year
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127569
|Principal Investigator:||Eric Oksenhendler, M.D.||AP-HP Hopital Saint-Louis|