Back to resultsEfficacy of Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With HIV Associated Non-Hodgkin's Lymphoma
Primary Purpose
AIDS Related Lymphoma
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
rituximab
CHOP
Sponsored by
About this trial
This is an interventional treatment trial for AIDS Related Lymphoma focused on measuring AIDS related Lymphoma, chemotherapy, rituximab
Eligibility 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
Sites / Locations
- Service de Medecine Interne Hopital Antoine Beclere
Outcomes
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
Full Information
NCT ID
NCT00126243
First Posted
August 2, 2005
Last Updated
August 16, 2005
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT00126243
Brief Title
Efficacy of Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With HIV Associated Non-Hodgkin's Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Terminated
Study Start Date
January 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Hoffmann-La Roche
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AIDS Related Lymphoma
Keywords
AIDS related Lymphoma, chemotherapy, rituximab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
CHOP
Primary Outcome Measure Information:
Title
Evaluate the response rate of lymphoma treated
Secondary Outcome Measure Information:
Title
Duration of response
Title
Evaluate the time to progression
Title
Survival
Title
Safety of rituximab in HIV patients with lymphoma when sequentially administered with chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Boue, MD
Organizational Affiliation
Service de Medecine Interne Hopital A Beclere Clamart France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dominique Costagliola
Organizational Affiliation
Inserm U 720
Official's Role
Study Chair
Facility Information:
Facility Name
Service de Medecine Interne Hopital Antoine Beclere
City
Clamart
ZIP/Postal Code
92140
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With HIV Associated Non-Hodgkin's Lymphoma
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