CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
Bexxar +3 moredrug
Likely dose
Acetaminophen 650 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00490009
NCT00490009Phase 2Completed

Phase 2 Study of Bexxar in Relapsed/Refractory Diffuse Large Cell Lymphoma (DLCL)

Susan Knox·interventional·Posted Jun 22, 2007·Updated Mar 30, 2017

In Brief

A Phase 2 clinical trial evaluating Bexxar, Acetaminophen, and 2 other interventions for Lymphoma. Completed, enrolled 9 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 22, 2007
Enrollment StartSep 1, 2004
Primary CompletionApr 1, 2010
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 19.0 years ago

Interventions

Bexxardrug

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

Acetaminophendrug

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

Diphenhydraminedrug

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

Potassium Iodide (KI)drug

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