Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00031902
Recruitment Status : Unknown
Verified February 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
Information provided by:
National Cancer Institute (NCI)

March 8, 2002
January 27, 2003
September 20, 2013
October 2001
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Complete list of historical versions of study NCT00031902 on Archive Site
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Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
Rituxumab Combined With Chemotherapy (PVB) For Poor Prognosis HIV-Related Non-Hodgkin's Lymphoma

RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with chemotherapy may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.


  • Determine the response rate of patients with poor-prognosis, HIV-related non-Hodgkin's lymphoma treated with rituximab combined with prednisolone, vincristine, and bleomycin.
  • Determine the toxicity of this regimen in these patients.
  • Determine the time to progression and survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive chemotherapy comprising vincristine IV and bleomycin IV on day 1 and oral prednisolone every other day beginning on day 1. Treatment repeats every 3 weeks for 6 courses. Patients also receive rituximab on days 14, 21, 28, and 35. Patients who achieve complete response (CR) receive 2 additional courses of chemotherapy after CR.

Patients are followed every 1-2 months.

PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study.

Phase 1
Primary Purpose: Treatment
  • Biological: bleomycin sulfate
  • Biological: rituximab
  • Drug: prednisolone
  • Drug: vincristine sulfate
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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  • Diagnosis of poor-prognosis, HIV-related non-Hodgkin's lymphoma (HIV-NHL)

    • Previously untreated
  • More than 1 of the following criteria:

    • Prior diagnosis of AIDS
    • ECOG performance status 3-4
    • CD4 count less than 100/mm3
  • No primary cerebral lymphoma



  • 18 and over

Performance status:

  • See Disease Characteristics

Life expectancy:

  • Not specified


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Biologic therapy:

  • Not specified


  • No prior chemotherapy for HIV-NHL
  • At least 1 year since prior chemotherapy for Kaposi's sarcoma (KS)

Endocrine therapy:

  • Not specified


  • Prior radiotherapy for HIV-NHL allowed
  • At least 1 year since prior radiotherapy for KS


  • Not specified
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
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Lymphoma Trials Office
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Study Chair: Ruth Pettengell, MD St. George's Hospital
National Cancer Institute (NCI)
February 2003

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