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Rituximab in the Treatment of HIV Associated Multicentric Castleman Disease Dependent on Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00127569
Recruitment Status : Terminated
First Posted : August 8, 2005
Last Update Posted : January 12, 2007
Hoffmann-La Roche
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Giant Lymph Node Hyperplasia Drug: Rituximab Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Primary Outcome Measures :
  1. Sustained response rate of multicentric Castleman disease at day 60, after 4 infusions of rituximab

Secondary Outcome Measures :
  1. One-year disease-free survival
  2. One-year event-free survival
  3. Relapse rate at day 365
  4. One-year lymphoma-free survival
  5. Tolerance of rituximab
  6. One-year overall survival
  7. Change in HHV-8 viral load within one year
  8. Change in lymphocyte B cell count within one year

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed multicentric Castleman disease, with dependence on vinblastine or VP16 for at least 3 months, whenever they have been splenectomized
  • At least one Castleman crisis since onset of chemotherapy
  • Ongoing highly active antiretroviral therapy (HAART) for at least 3 months
  • No threshold of CD4 cell count and HIV-RNA
  • Signed written informed consent

Exclusion Criteria:

  • Prior treatment with rituximab
  • Evolutive lymphoma or Kaposi's sarcoma needing treatment
  • Absence of effective contraception
  • Pregnancy

Information from the National Library of Medicine

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 identifier (NCT number): NCT00127569

Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Hoffmann-La Roche
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Principal Investigator: Eric Oksenhendler, M.D. AP-HP Hopital Saint-Louis
Layout table for additonal information Identifier: NCT00127569    
Other Study ID Numbers: ANRS 117 CastlemaB
First Posted: August 8, 2005    Key Record Dates
Last Update Posted: January 12, 2007
Last Verified: January 2007
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HIV infections
Giant Lymph Node Hyperplasia
Herpesvirus 8, Human
Rituximab (Mabthera)
Antibodies, Monoclonal
Additional relevant MeSH terms:
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HIV Infections
Castleman Disease
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents