Clinical trial NCT00126243: Efficacy of Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With HIV Associated Non-Hodgkin's Lymphoma
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: AIDS Related Lymphoma
Keywords: AIDS related Lymphoma
chemotherapy
rituximab
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
Collaborators: name: Hoffmann-La Roche
First posted: 2005-08-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the response rate of lymphoma treated
Secondary outcomes:
measure: Duration of response
measure: Evaluate the time to progression
measure: Survival
measure: Safety of rituximab in HIV patients with lymphoma when sequentially administered with chemotherapy
Other outcomes:
Locations:
city: Clamart
country: France
facility: Service de Medecine Interne Hopital Antoine Beclere
Study officials:
affiliation: Service de Medecine Interne Hopital A Beclere Clamart France
name: Francois Boue, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inserm U 720
name: Dominique Costagliola
role: STUDY_CHAIR
References: