Clinical Trial: Efficacy of Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With HIV Associated Non-Hodgkin’s Lymphoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Multicenter, Open Label, Phase II Trial to Evaluate the Efficacy and Safety of Treatment With Rituximab + CHOP Regimen in Patients With HIV Related Non-Hodgkin’s Lymphomas. ANRS 085 Rituximab

Brief Summary: Most treatment procedures in AIDS-related lymphomas disclose a relatively poor outcome for patients with low response rates, high number of relapses and AIDS events. The addition of rituximab to the standard regimen - CHOP could improve the outcome of these patients. The aim of the trial is to evaluate the safety and efficacy of rituximab when added to the CHOP regimen in patients with newly diagnosed AIDS-related non-Hodgkin lymphoma.

Detailed Summary: HIV infection is associated with a high incidence of AIDS-related lymphomas (ARL). Since the use of highly active antiretroviral therapy (HAART), the incidence of AIDS-defining illnesses has decreased, leading to a significant improvement in survival of HIV-infected patients. The incidence of ARL has decreased in a lower degree and lymphoma remains the major cause of death of HIV patients. Most treatment procedures disclose a relatively poor outcome of patients with low response rates, high number of relapses and AIDS events. Since the majority of HIV-associated NHL are CD20-positive the addition of rituximab to the standard regimen - CHOP could improve the outcome of these patients
Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Current Primary Outcome: Evaluate the response rate of lymphoma treated

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of response
  • Evaluate the time to progression
  • Survival
  • Safety of rituximab in HIV patients with lymphoma when sequentially administered with chemotherapy


Original Secondary Outcome: Same as current

Information By: French National Agency for Research on AIDS and Viral Hepatitis

Dates:
Date Received: August 2, 2005
Date Started: January 1999
Date Completion: October 2003
Last Updated: August 16, 2005
Last Verified: August 2005