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

This study has been terminated.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00127569
First received: August 4, 2005
Last updated: January 11, 2007
Last verified: January 2007

August 4, 2005
January 11, 2007
May 2003
Not Provided
Sustained response rate of multicentric Castleman disease at day 60, after 4 infusions of rituximab
Complete response rate of multicentric Castleman disease at day 60, after 4 infusions of rituximab
Complete list of historical versions of study NCT00127569 on ClinicalTrials.gov Archive Site
  • 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
  • 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 lymphocytes B cell count within one year
Not Provided
Not Provided
 
Rituximab in the Treatment of HIV Associated Multicentric Castleman Disease Dependent on Chemotherapy
Multicenter, Phase II Trial Assessing the Efficacy of Rituximab in HIV Infected Patients With Multicentric Castleman Disease Dependent on Chemotherapy (ANRS 117 Study, CastlemaB)

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Giant Lymph Node Hyperplasia
Drug: Rituximab
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
January 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00127569
ANRS 117 CastlemaB
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
Hoffmann-La Roche
Principal Investigator: Eric Oksenhendler, M.D. AP-HP Hopital Saint-Louis
French National Agency for Research on AIDS and Viral Hepatitis
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP