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

This study has been terminated.

Sponsor:

Collaborator:

Hoffmann-La Roche

Information provided by:

French National Agency for Research on AIDS and Viral Hepatitis

ClinicalTrials.gov Identifier:

NCT00126243

First received: August 2, 2005

Last updated: August 16, 2005

Last verified: August 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

August 2, 2005

Last Updated Date

August 16, 2005

Start Date ^ICMJE

January 1999

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Evaluate the response rate of lymphoma treated

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00126243 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

AIDS Related Lymphoma

Intervention ^ICMJE

Drug: rituximab
Drug: CHOP

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

October 2003

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00126243

Other Study ID Numbers ^ICMJE

ANRS 085 Rituximab

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators ^ICMJE

Hoffmann-La Roche

Investigators ^ICMJE

Principal Investigator:	Francois Boue, MD	Service de Medecine Interne Hopital A Beclere Clamart France
Study Chair:	Dominique Costagliola	Inserm U 720

Information Provided By

French National Agency for Research on AIDS and Viral Hepatitis

Verification Date

August 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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