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

Sponsors and Collaborators:	French National Agency for Research on AIDS and Viral Hepatitis Hoffmann-La Roche
Information provided by:	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT00126243

Purpose

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	Intervention	Phase
AIDS Related Lymphoma	Drug: rituximab Drug: CHOP	Phase II

MedlinePlus related topics: AIDS Lymphoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Prednisone Vincristine sulfate Vincristine Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:

Evaluate the response rate of lymphoma treated

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	January 1999
Estimated Study Completion Date:	October 2003

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126243

Locations

France
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

More Information

Study ID Numbers:	ANRS 085 Rituximab
Study First Received:	August 2, 2005
Last Updated:	August 16, 2005
ClinicalTrials.gov Identifier:	NCT00126243
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

AIDS related Lymphoma
chemotherapy
rituximab

Study placed in the following topic categories:

Lymphoma, AIDS-related
Prednisone
Immunoproliferative Disorders
Rituximab
Primary effusion lymphoma
Acquired Immunodeficiency Syndrome
Lymphoma, small cleaved-cell, diffuse
Vincristine
Cyclophosphamide

Doxorubicin
Lymphoma, B-Cell
Lymphatic Diseases
Lymphoma, AIDS-Related
HIV Infections
B-cell lymphomas
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009