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)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: bleomycin sulfate Biological: rituximab Drug: prednisolone Drug: vincristine sulfate Phase 1

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Rituxumab Combined With Chemotherapy (PVB) For Poor Prognosis HIV-Related Non-Hodgkin's Lymphoma
Study Start Date : October 2001

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • Not specified


  • Not specified


  • Not specified


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00031902

United Kingdom
St. George's Hospital
London, England, United Kingdom, SW17 0QT
Chelsea Westminster Hospital
London, United Kingdom, SW10 9NH
Sponsors and Collaborators
Lymphoma Trials Office
Study Chair: Ruth Pettengell, MD St. George's Hospital Identifier: NCT00031902     History of Changes
Other Study ID Numbers: CDR0000069238
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: February 2003

Keywords provided by National Cancer Institute (NCI):
AIDS-related peripheral/systemic lymphoma
AIDS-related diffuse large cell lymphoma
AIDS-related immunoblastic large cell lymphoma
AIDS-related small noncleaved cell lymphoma
AIDS-related diffuse mixed cell lymphoma
AIDS-related diffuse small cleaved cell lymphoma
AIDS-related lymphoblastic lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antibiotics, Antineoplastic