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

• Status: Terminated
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborator: Hoffmann-La Roche
• Treatments: Rituximab

Criteria

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