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Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma

NCT00510887 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2014-05-12

Study results available
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Summary

The purpose of this study is to evaluate the effectiveness and safety of combining bortezomib (Velcade) with rituximab, fludarabine, mitoxantrone, and dexamethasone in treating patients with follicular cell lymphoma.

Conditions

  • Lymphoma, Follicular

Interventions

DRUG

Bortezomib

Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle

DRUG

Rituximab

Rituximab 375 mg/m2 IV on day 1

DRUG

Fludarabine

Fludarabine 25 mg/m2 IV on days 1,2,3

DRUG

Mitoxantrone

Mitoxantrone 10 mg/m2 IV on day 2

DRUG

Dexamethasone

Dexamethasone 20 mg orally on days 1,2,3,4,5

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Duke University

    lead OTHER

Principal Investigators

  • David A Rizzieri, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2012-11-30
Completion
2013-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00510887 on ClinicalTrials.gov