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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00126243

Enrollment

Registered

2005-08-03

Start date

1999-01-31

Completion date

2003-10-31

Last updated

2005-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS Related Lymphoma

Keywords

AIDS related Lymphoma, chemotherapy, rituximab

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

Interventions

DRUGrituximab

DRUGCHOP

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Evaluate the response rate of lymphoma treated	—

Secondary

Measure	Time frame
Duration of response	—
Evaluate the time to progression	—
Survival	—
Safety of rituximab in HIV patients with lymphoma when sequentially administered with chemotherapy	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026