A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma (RATE)

Last updated: April 10, 2017
Sponsor: Genentech, Inc.
Overall Status: Completed

Phase

3

Condition

Lymphoma

Lymphoproliferative Disorders

Follicular Lymphoma

Treatment

CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone)

Rituximab

Analgesic/antipyretic and antihistamine drugs

Clinical Study ID

NCT00719472
U4391g
  • Ages > 18
  • All Genders

Study Summary

This was a prospective, open-label, Phase III, multicenter, single-arm trial designed to assess the safety, pharmacokinetics, and pharmacodynamics of an alternative dosing rate of rituximab in previously untreated patients with diffuse large B-cell lymphoma (DLBCL) and follicular non-Hodgkin lymphoma (NHL).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent

  • Age ≥ 18 years

  • Patients with previously untreated diffuse large B-cell lymphoma (DLBCL) who arescheduled to receive rituximab 375 mg/m^2 plus CHOP (cyclophosphamide,hydroxydaunorubicin [also called doxorubicin or adriamycin], Oncovin [vincristine],prednisone or prednisolone) chemotherapy, or previously untreated follicularnon-Hodgkin lymphoma (NHL) who are scheduled to receive rituximab 375 mg/m^2 plus CVP (cyclophosphamide, vincristine, prednisolone) chemotherapy

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion

Exclusion Criteria:

  • Clinically significant cardiovascular disease (eg, uncontrolled hypertension, myocardialinfarction, unstable angina), New York Heart Association (NYHA) Classification Grade II orgreater congestive heart failure, a ventricular arrhythmia requiring medication within 1year prior to Day 1, or NYHA Grade II or greater peripheral vascular disease on Day 1 (first day of treatment) Patients who meet any of the following criteria will be excluded from further studyparticipation after Cycle 1:
  • Circulating lymphocyte count > 5,000/μL before the Cycle 2 rituximab infusion

  • Development of a serious and/or Grade 3 or 4 adverse event during Cycle 1 judged bythe investigator to be related to the rituximab infusion

  • Prior premedication with additional corticosteroids other than the prednisone includedin the chemotherapy regimens

Study Design

Total Participants: 451
Treatment Group(s): 4
Primary Treatment: CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone)
Phase: 3
Study Start date:
July 01, 2008
Estimated Completion Date:
May 31, 2011

Connect with a study center

  • Birmingham Hem Onc, LLC

    Birmingham, Alabama 35213
    United States

    Site Not Available

  • Clearview Cancer Institute

    Huntsville, Alabama 35805
    United States

    Site Not Available

  • Arizona Clinical Research Ctr

    Tucson, Arizona 85715
    United States

    Site Not Available

  • Clopton Clinic

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Pacific Cancer Medical Center

    Anaheim, California 92801
    United States

    Site Not Available

  • California Cancer Care Inc

    Greenbrae, California 94904
    United States

    Site Not Available

  • Wilshire Onc Med Group, Inc.

    La Verne, California 91750
    United States

    Site Not Available

  • Medical Oncology Care Assoc

    Orange, California 92868
    United States

    Site Not Available

  • Bay Area Cancer Research Grp

    Pleasant Hill, California 94523
    United States

    Site Not Available

  • Los Palos Oncology & Hem

    Salinas, California 93901
    United States

    Site Not Available

  • Tri-Valley Onc-Hem Assoc

    Westlake Village, California 91361
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers

    Denver, Colorado 80218
    United States

    Site Not Available

  • Medical Specialists of Fairfie

    Fairfield, Connecticut 06824
    United States

    Site Not Available

  • Hematology Oncology, PC

    Stamford, Connecticut 06902
    United States

    Site Not Available

  • North Broward Medical Center

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Gainesville Hem/Onc Assoc

    Gainesville, Florida 32605
    United States

    Site Not Available

  • Integrated Community Onc Ntw

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Florida Cancer Institute

    New Port Richey, Florida 34655
    United States

    Site Not Available

  • Hem Onc Assoc of C Brevard

    Rockledge, Florida 32955
    United States

    Site Not Available

  • NW Georgia Oncology Ctrs PC

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Atlanta Cancer Care

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Rush Cancer Institute

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Medical & Surgical Specialists

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Joliet Hem/Onc Associates

    Joliet, Illinois 60435
    United States

    Site Not Available

  • N Shore Cancer Research Assoc

    Skokie, Illinois 60076
    United States

    Site Not Available

  • Carle Clinic

    Urbana, Illinois 61801
    United States

    Site Not Available

  • University of Iowa Hospital

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Cancer Center of Kansas

    Wichita, Kansas 67214-3728
    United States

    Site Not Available

  • Kentucky Cancer Clinic

    Hazard, Kentucky 41701
    United States

    Site Not Available

  • Hem & Onc Specialists

    Metairie, Louisiana 70006-2936
    United States

    Site Not Available

  • Annapolis Oncology Ctr

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Sinai Hospital of Baltimore

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • Maryland Oncology/Hema PA

    Columbia, Maryland 21044
    United States

    Site Not Available

  • Omoh Pc

    Woodhaven, Michigan 48138
    United States

    Site Not Available

  • Saint Louis Cancer Care, LLP

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Heartland Hematology-Oncology

    Kansas City, Missouri 64118
    United States

    Site Not Available

  • Montana Cancer Specialists

    Missoula, Montana 59802
    United States

    Site Not Available

  • Dartmouth Hitchcock Med Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Portsmouth Regional Hospital

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Essex Hematology Oncology

    Belleville, New Jersey 07109
    United States

    Site Not Available

  • Oncology & Hema Specialists PA

    Denville, New Jersey 07834
    United States

    Site Not Available

  • Hem Onc Assoc of Northern NJ

    Morristown, New Jersey 07962
    United States

    Site Not Available

  • Zale P Bernstein MD - PP

    Buffalo, New York 14215
    United States

    Site Not Available

  • Queens Medical Associates P.C.

    Fresh Meadows, New York 11366
    United States

    Site Not Available

  • Huntington Medical Group, PC

    Huntington, New York 11746
    United States

    Site Not Available

  • Hem Onc Assoc of Rockland

    Nyack, New York 10960
    United States

    Site Not Available

  • Cancer Care of Western NC

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Alamance Regional Med Center

    Burlington, North Carolina 27515
    United States

    Site Not Available

  • Carolina Onc Specialists, PA

    Hickory, North Carolina 28602
    United States

    Site Not Available

  • Carolina BioOncology Institute

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Summa Health System

    Akron, Ohio 44304
    United States

    Site Not Available

  • Gabrail Cancer Center

    Canton, Ohio 44718
    United States

    Site Not Available

  • MetroHealth Medical Center

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • Signal Point Clin Res Ctr LLC

    Middletown, Ohio 45042
    United States

    Site Not Available

  • Pacific Oncology, PC

    Portland, Oregon 97210
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Central PA Hematology & Medica

    Lemoyne, Pennsylvania 17043
    United States

    Site Not Available

  • South Carolina Cancer Spec

    Hilton Head Island, South Carolina 29926
    United States

    Site Not Available

  • Santee Hematology/Oncology

    Sumter, South Carolina 29150
    United States

    Site Not Available

  • Blue Ridge Medical Specialists

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • McLeod Cancer & Blood Center

    Johnson City, Tennessee 37604
    United States

    Site Not Available

  • Family Cancer Center, PLLC

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Coastal Bend Cancer Center

    Corpus Christi, Texas 78463
    United States

    Site Not Available

  • Dallas Oncology Consultants

    Duncanville, Texas 75137
    United States

    Site Not Available

  • Hem Onc Assoc of South Texas

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Northern Utah Associates

    Ogden, Utah 84403
    United States

    Site Not Available

  • Blue Ridge Cancer Center

    Salem, Virginia 24153
    United States

    Site Not Available

  • Columbia Basin Hem-Onc

    Kennewick, Washington 99336
    United States

    Site Not Available

  • St. Mary Medical Center

    Walla Walla, Washington 99362
    United States

    Site Not Available

  • Vince Lombardi Cancer Center

    Green Bay, Wisconsin 54311
    United States

    Site Not Available

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