A Phase I/II Trial of VR-CHOP in Lymphoma Patients

NCT00634179 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2016-10-27

Study results available
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Summary

This is an open-label (doctors and patients know which drug will be given), single center, phase 1/2 clinical trial. The primary objective is to determine whether VR-CHOP provides benefit to patients with previously untreated indolent non-Hodgkin's lymphomas (NHL).

Conditions

Interventions

DRUG

Bortezomib

Bortezomib 1.6 mg/m² given on days 1 and 8

BIOLOGICAL

Rituximab

Rituximab 375 mg/m²

DRUG

Doxorubicin

Doxorubicin 50 mg/m²

DRUG

Cyclophosphamide

Cyclophosphamide 750 mg/m²

DRUG

Vincristine

Vincristine 1.4 mg/m² (capped at 1.5 mg maximum) given on day 1

DRUG

Prednisone

Prednisone 100 mg/day given orally on days 1-5

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY
  • Emory University

    lead OTHER

Principal Investigators

  • Christopher Flowers, MD · Emory 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
2008-02-29
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

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Entities

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 NCT00634179 on ClinicalTrials.gov