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Chemotherapy Followed by Zevalin for Relapsed Mantle Cell Lymphoma

NCT00119730 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-04-24

No results posted yet for this study

Summary

* The purpose of this study is to find out whether combining a short course of chemotherapy (Fludarabine, Mitoxantrone and Rituximab) followed by Zevalin will be effective in treating relapsed mantle cell lymphoma.
* The secondary purposes of the study are to determine the safety and to evaluate whether there is additional benefit from Zevalin therapy following the chemotherapy.

Conditions

Interventions

DRUG

Fludarabine

Given on days 1-3 of each 28-day cycle

DRUG

Mitoxantrone

Given on day 1 of each 28-day cycle

DRUG

Rituximab

Given on day 1 of each 28-day cycle

DRUG

Zevalin

After two cycles if there is no disease progression, zevalin treatment will be given. Rituximab will be given followed by an imaging dose of zevalin. Two or three scans will be performed over a week to determine if it is safe to give the full treatment dose of zevalin. The treatment dose is given with the second infusion or rituximab, seven days after the first dose.

Sponsors & Collaborators

Principal Investigators

  • Jennifer R Brown, MD, PhD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2006-12-31
Completion
2013-12-31

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 NCT00119730 on ClinicalTrials.gov