- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00126243
Efficacy of Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With HIV Associated Non-Hodgkin's Lymphoma
August 16, 2005 updated by: French National Agency for Research on AIDS and Viral Hepatitis
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Interventional
Enrollment
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Clamart, France, 92140
- Service de Medecine Interne Hopital Antoine Beclere
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Evaluate the response rate of lymphoma treated
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Secondary Outcome Measures
Outcome Measure |
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Duration of response
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Survival
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Evaluate the time to progression
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Safety of rituximab in HIV patients with lymphoma when sequentially administered with chemotherapy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Dominique Costagliola, INSERM U 720
- Principal Investigator: Francois Boue, MD, Service de Medecine Interne Hopital A Beclere Clamart France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1999
Study Completion
October 1, 2003
Study Registration Dates
First Submitted
August 2, 2005
First Submitted That Met QC Criteria
August 2, 2005
First Posted (Estimate)
August 3, 2005
Study Record Updates
Last Update Posted (Estimate)
August 17, 2005
Last Update Submitted That Met QC Criteria
August 16, 2005
Last Verified
August 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, B-Cell
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, AIDS-Related
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- ANRS 085 Rituximab
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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