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

NCT ID: NCT00031902

Last Updated: 2013-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Brief Summary

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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.

Detailed Description

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OBJECTIVES:

* 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.

Conditions

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Lymphoma

Keywords

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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

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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bleomycin sulfate

Intervention Type BIOLOGICAL

rituximab

Intervention Type BIOLOGICAL

prednisolone

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* 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

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* See Disease Characteristics

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

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

Endocrine therapy:

* Not specified

Radiotherapy:

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

Surgery:

* Not specified
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lymphoma Trials Office

OTHER

Sponsor Role lead

Principal Investigators

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Ruth Pettengell, MD

Role: STUDY_CHAIR

St. George's Hospital

Locations

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St. George's Hospital

London, England, United Kingdom

Site Status

Chelsea Westminster Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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BNLI-POORRISKHIV

Identifier Type: -

Identifier Source: secondary_id

EU-20145

Identifier Type: -

Identifier Source: secondary_id

CDR0000069238

Identifier Type: -

Identifier Source: org_study_id