Rituximab in the Treatment of HIV Associated Multicentric Castleman Disease Dependent on Chemotherapy
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections Giant Lymph Node Hyperplasia |
Drug: Rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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) |
- 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
| Estimated Enrollment: | 25 |
| Study Start Date: | May 2003 |
| Estimated Study Completion Date: | January 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00127569 History of Changes |
| Other Study ID Numbers: | ANRS 117 CastlemaB |
| Study First Received: | August 4, 2005 |
| Last Updated: | January 11, 2007 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
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:
|
HIV Infections Acquired Immunodeficiency Syndrome Giant Lymph Node Hyperplasia Hyperplasia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Pathologic Processes Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 21, 2013