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

Sponsor
French National Agency for Research on AIDS and Viral Hepatitis (Other)
Overall Status
Terminated
CT.gov ID
NCT00126243
Collaborator
Hoffmann-La Roche (Industry)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Jan 1, 1999
Study Completion Date :
Oct 1, 2003

Outcome Measures

Primary Outcome Measures

  1. Evaluate the response rate of lymphoma treated []

Secondary Outcome Measures

  1. Duration of response []

  2. Evaluate the time to progression []

  3. Survival []

  4. Safety of rituximab in HIV patients with lymphoma when sequentially administered with chemotherapy []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service de Medecine Interne Hopital Antoine Beclere Clamart France 92140

Sponsors and Collaborators

  • French National Agency for Research on AIDS and Viral Hepatitis
  • Hoffmann-La Roche

Investigators

  • Principal Investigator: Francois Boue, MD, Service de Medecine Interne Hopital A Beclere Clamart France
  • Study Chair: Dominique Costagliola, Inserm U 720

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00126243
Other Study ID Numbers:
  • ANRS 085 Rituximab
First Posted:
Aug 3, 2005
Last Update Posted:
Aug 17, 2005
Last Verified:
Aug 1, 2005

Study Results

No Results Posted as of Aug 17, 2005