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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-01-31

Study Completion Date

2003-10-31

Brief Summary

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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

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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

Conditions

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AIDS Related Lymphoma

Keywords

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AIDS related Lymphoma chemotherapy rituximab

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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rituximab

Intervention Type DRUG

CHOP

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Francois Boue, MD

Role: PRINCIPAL_INVESTIGATOR

Service de Medecine Interne Hopital A Beclere Clamart France

Dominique Costagliola

Role: STUDY_CHAIR

Inserm U 720

Locations

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Service de Medecine Interne Hopital Antoine Beclere

Clamart, , France

Site Status

Countries

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France

Other Identifiers

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ANRS 085 Rituximab

Identifier Type: -

Identifier Source: org_study_id