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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


Phase 2
18 Years
75 Years
Not Enrolling
Both
AIDS Related Lymphoma

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the response rate of lymphoma treated

Principal Investigator

Francois Boue, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Service de Medecine Interne Hopital A Beclere Clamart France

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

ANRS 085 Rituximab

NCT ID:

NCT00126243

Start Date:

January 1999

Completion Date:

October 2003

Related Keywords:

  • AIDS Related Lymphoma
  • AIDS related Lymphoma
  • chemotherapy
  • rituximab
  • Acquired Immunodeficiency Syndrome
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, AIDS-Related

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