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Phase 2 Study of Bexxar in Relapsed/Refractory DLCL

NCT00490009 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-03-30

Study results available
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Summary

The purpose of this study is to obtain safety and efficacy data using Bexxar in patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL).

Conditions

Interventions

DRUG

Bexxar

Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. The radioactive isotope then gives off radiation, which kills the cells. Bexxar will be administered to provide the following patient-specific radiotherapy: * Platelet count of 150,000/mm³ = 75 cGy * Platelet count ≥ 100,000/mm³ but \< 150,000/mm³ = 65 cGy

DRUG

Acetaminophen

As premedication 30 to 60 minutes before antibody infusion; 650 mg, oral. Used to as to relieve pain

DRUG

Diphenhydramine

As premedication 30 to 60 minutes before antibody infusion; 50 mg, oral. Used to prevent inflammation or allergic reactions

DRUG

Potassium Iodide (KI)

Administered to prevent thyroid blockage 130 mg orally 3 times a day,

Sponsors & Collaborators

  • Corixa Corporation

    collaborator INDUSTRY

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Susan Knox

    lead OTHER

Principal Investigators

  • Susan J Knox · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2010-04-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00490009 on ClinicalTrials.gov