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

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:
NCT00126243
First received: August 2, 2005
Last updated: August 16, 2005
Last verified: August 2005

August 2, 2005
August 16, 2005
January 1999
Not Provided
Evaluate the response rate of lymphoma treated
Same as current
Complete list of historical versions of study NCT00126243 on ClinicalTrials.gov Archive Site
  • Duration of response
  • Evaluate the time to progression
  • Survival
  • Safety of rituximab in HIV patients with lymphoma when sequentially administered with chemotherapy
Same as current
Not Provided
Not Provided
 
Efficacy of Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With HIV Associated Non-Hodgkin’s Lymphoma
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

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.

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

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
AIDS Related Lymphoma
  • Drug: rituximab
  • Drug: CHOP
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
60
October 2003
Not Provided

Inclusion Criteria:

  • HIV positive with a high grade Ann Arbor stage I to IV untreated non-Hodgkin’s lymphoma of B-cell origin confirmed by biopsy. The following histologies are eligible: *Burkitt’s lymphoma, *diffuse large B-cell with standard histological diagnosis, *Burkitt-like and high grade large cell immunoblastic lymphoma with immunophenotyping CD20 positive
  • Good and intermediate prognostic group (no more than one of the following prognostic factors: *CD4 below 100/µl, *history of opportunistic infection, *Karnofsky index below 60 percent or ECOG over 2)
  • Written inform consent to participate

Exclusion Criteria:

  • Active viral hepatitis
  • Pregnancy
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00126243
ANRS 085 Rituximab
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
Hoffmann-La Roche
Principal Investigator: Francois Boue, MD Service de Medecine Interne Hopital A Beclere Clamart France
Study Chair: Dominique Costagliola Inserm U 720
French National Agency for Research on AIDS and Viral Hepatitis
August 2005

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