NCT00031902

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2002

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 20, 2013

Status Verified

February 1, 2003

First QC Date

March 8, 2002

Last Update Submit

September 19, 2013

Conditions

Lymphoma

Keywords

AIDS-related peripheral/systemic lymphomaAIDS-related diffuse large cell lymphomaAIDS-related immunoblastic large cell lymphomaAIDS-related small noncleaved cell lymphomaAIDS-related diffuse mixed cell lymphomaAIDS-related diffuse small cleaved cell lymphomaAIDS-related lymphoblastic lymphoma

Interventions

bleomycin sulfateBIOLOGICAL
rituximabBIOLOGICAL
prednisoloneDRUG
vincristine sulfateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

St. George's Hospital

London, England, SW17 0QT, United Kingdom

Location

Chelsea Westminster Hospital

London, SW10 9NH, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma

Interventions

BleomycinRituximabPrednisoloneVincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Ruth Pettengell, MD

    St. George's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 8, 2002

First Posted

January 27, 2003

Study Start

October 1, 2001

Last Updated

September 20, 2013

Record last verified: 2003-02

Locations

GB(2)