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Efficacy of Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With HIV Associated Non-Hodgkin’s Lymphoma
This study has been terminated.
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
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
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Rituximab
Genetic and Rare Diseases Information Center resources:
Lymphosarcoma
Lymphoma AIDS Related
Primary Effusion Lymphoma
B-cell Lymphoma
U.S. FDA Resources
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 |
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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00126243
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
| ClinicalTrials.gov Identifier: | NCT00126243 History of Changes |
| Other Study ID Numbers: |
ANRS 085 Rituximab |
| Study First Received: | August 2, 2005 |
| Last Updated: | August 16, 2005 |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
|
AIDS related Lymphoma chemotherapy rituximab |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, AIDS-Related Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Lymphoma, B-Cell Rituximab Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on August 18, 2017