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Comparative trial for pixantrone in combination with rituximab in indolent non-Hodgkin's lymphoma

This study is currently recruiting patients.

Sponsored by: Novuspharma
Information provided by: Novuspharma

Purpose

The purpose of this study is to determine whether combining pixantrone (BBR 2778, INN name pending) with the monoclonal antibody rituximab, leads to an increase in the period of patients’ remission, compared to rituximab alone.

Condition Treatment or Intervention Phase
Lymphoma, Follicular
Lymphoma, Mixed-Cell, Follicular
Lymphoma, Small Cleaved-Cell, Follicular
Lymphoma, Low-Grade
  Drug: rituximab
 Drug: Pixantrone (BBR 2778)
 Phase III

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title: An Open-Label, Randomized, Phase III Comparative Trial of BBR 2778 + Rituximab Versus Rituximab in the Treatment of Patients with Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma (NHL)

Further Study Details: 

Expected Total Enrollment:  800

This trial is being conducted in patients with indolent (or low-grade) non-Hodgkin’s lymphoma, who have either relapsed or been refractory to previous treatment.

Pixantrone belongs to the DNA intercalator family of chemotherapy agents, which includes anthracyclines. DNA intercalators are commonly used to treat patients with indolent NHL, often in combination with the monoclonal antibody rituximab. This study represents the first large-scale, comparative trial in indolent NHL, designed to determine whether the response rate and time to tumour progression in patients treated with a combination of rituximab and a DNA intercalator, is significantly higher than seen in patients treated with rituximab alone.

This trial is randomized and controlled, which means that participating patients will be randomly assigned to one of two treatment groups:

1) Patients treated with both pixantrone and rituximab, in combination

2) Patients treated with only rituximab

This trial is expected to recruit around 800 patients in the US, Europe and Israel, with 400 patients recruited to each group.

Patients will be treated for around 18 weeks and will recieve regular physician monitoring for five years from the end of treatment.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

Exclusion criteria:


Location and Contact Information


Arizona
      Arizona Clinical Research Center, Tucson,  Arizona,  85712,  United States; Not yet recruiting
Patricia M. Plezia, Pharm D  520-290-2510    pplezia@earthlink.net 
Manuel Modiano, MD
Manuel Modiano, MD,  Principal Investigator
Patricia M. Plezia, Pharm D,  Sub-Investigator

California
      Sutter Health Western Division Cancer Research Group, Greenbrae,  California,  94904,  United States; Recruiting
Lyssa Friedman  415-925-7916    FriedmL@sutterhealth.org 
Ari Baron, MD
Ari Baron, MD,  Principal Investigator
Lyssa Friedman,  Sub-Investigator

      Kenmar Research Institute, Los Angeles,  California,  90057,  United States; Recruiting
Anne Kennedy  213-386-1888    anne@kenmarresearch.com 
Eduardo Lim, MD
Eduardo Lim, MD,  Principal Investigator
Anne Kennedy,  Sub-Investigator

Colorado
      Rocky Moutain Cancer Center, Denver,  Colorado,  80218,  United States; Not yet recruiting
Joni Newman  303-388-4876 
Jeffery Matous, MD
Jeffery Matous, MD,  Principal Investigator
Joni Newman,  Sub-Investigator

Florida
      Pasco, Hernando Oncology Associates, P.A., New Port Richey,  Florida,  United States; Recruiting
Eve Crosariol  727-842-2795  Ext. 215    eve.phoa@tampabaydsl.com 
K. Kumar, MD
Eve Crosariol,  Sub-Investigator
K Kumar, MD,  Principal Investigator

      Ocala Oncology Center, Ocala,  Florida,  34474,  United States; Recruiting
Renee Genther  352-732-4938    renee.genther@usoncology.com 
Craig Reynolds, MD
Craig Reynolds, MD,  Principal Investigator
Renee Genther,  Sub-Investigator

      Orange Park Cancer Center, Orange Park,  Florida,  32073,  United States; Recruiting
Carla Malott  904-272-3139    carla.malott@foa.cc 
Linda Sylvester, MD   linda.sylvester@usoncology.com 
Linda Sylvester, MD,  Principal Investigator
Carla Malott,  Sub-Investigator

Illinois
      Edward Cancer Center, Naperville,  Illinois,  60540,  United States; Recruiting
Kathy Seymour  630-527-3787    Kseymour@edward.org 
Joseph Kash, MD
Joseph Kash, MD,  Principal Investigator
Kathy Seymour,  Sub-Investigator

      University of Chicago Medical Center Hematology / Oncology, Chicago,  Illinois,  60637,  United States; Not yet recruiting
Kathy Atwater, RN  773-702-2034    katwater@medicine.bsd.uchicago.edu 
Sonali Smith, MD   smsmith@medicine.bsd.uchicago.edu 
Sonali Smith, MD,  Principal Investigator
Kathy Atwater, RN,  Sub-Investigator

      Illinois Masonic Cancer Center, Chicago,  Illinois,  60657,  United States; Not yet recruiting
Ken Ziganto  773-296-5360    ken.ziganto@advocatehealth.com 
Samuel Taylor, MD
Samuel Taylor, MD,  Principal Investigator
Ken Ziganto,  Sub-Investigator

Indiana
      Hope Center, Terre Haute,  Indiana,  47802,  United States; Recruiting
Jacquelyn Bradfield  812-234-0098    jacquelyn.bradfield@impath.com 
Ashis Chakrabarti, MD
Ashis Chakrabarti, MD,  Principal Investigator
Jacquelyn Bradfield,  Sub-Investigator

Kentucky
      Commonwealth Hematology/Oncology, Danville,  Kentucky,  40422,  United States; Recruiting
Julie Jones  859-236-2203    juliejones@adelphia.net 
Thomas Baeker, MD   cancercareky@aol.com 
Thomas Baeker, MD,  Principal Investigator
Julie Jones,  Sub-Investigator

Massachusetts
      New England Hematology / Oncology Associates, Wellesley,  Massachusetts,  02481,  United States; Recruiting
Eileen Capstraw  781-237-5591    ecapstraw@neho.org 
Marcia Browne, MD
Marcia Browne, MD,  Principal Investigator
Eileen Capstraw,  Sub-Investigator

Missouri
      St. Joseph Oncology, St. Joseph,  Missouri,  64507,  United States; Recruiting
Bob Moore  816-271-1032    bob.moore@impath.com 
Raj Rangineni, MD
Raj Rangineni, MD,  Principal Investigator
Bob Moore,  Sub-Investigator

      St. Johns Mercy Medical Center, St. Louis,  Missouri,  63141,  United States; Recruiting
Christy Hill, RN  314-569-6933  Ext. 5185    chill@tcccr.com 
Nelida Sjak-Shie, MD PhD
Nelida Sjak-Shie, MD PhD,  Principal Investigator
Christy Hill, RN,  Sub-Investigator

      Christian Hospital, St. Louis,  Missouri,  63136,  United States; Recruiting
Hellen Mullner  314-355-5597    helen.mullner@impath.com 
Mark Woodson, MD
Mark Woodson, MD,  Principal Investigator
Hellen Mullner,  Sub-Investigator

Montana
      Hematology - Oncology Centers of N. Rockies, Billings,  Montana,  59101,  United States; Recruiting
Mary Van Zandt, RN OCN  406-238-6962    mary.vanzandt@impath.com 
Patrick Cobb, MD  406-238-6962 
Patrick Cobb, MD,  Principal Investigator
Mary Van Zandt, RN OCN,  Sub-Investigator

      Great Falls Clinic, Great Falls,  Montana,  59405,  United States; Recruiting
Bernadette Mundt, RN BSN OCN  406-452-6657    bernadette.mundt@impath.com 
Grant Harrer, MD
Grant Harrer, MD,  Principal Investigator
Bernadette Mundt, RN BSN OCN,  Sub-Investigator

New Jersey
      Hematology Oncology Associates of NJ, Paramus,  New Jersey,  07652,  United States; Recruiting
Jessica Bird, RN  201-634-5353    jessica.bird@impath.com 
Barry Fernbach, MD
Barry Fernbach, MD,  Principal Investigator
Jessica Bird, RN,  Sub-Investigator

      East Orange VA Medical Center, East Orange,  New Jersey,  07018,  United States; Recruiting
Xianwen Qiau  973-395-7087    xianwen.qiao@med.va.gov 
Shawthi Srinivas, MD
Shawthi Srinivas, MD,  Principal Investigator
Xianwen Qiau,  Sub-Investigator

      Summit Medical Group/Overlook Onc Center, Summit,  New Jersey,  07901,  United States; Recruiting
Vanessa DePaul  908-273-4300  Ext. 5131    Vanessa.depaul@impath.com 
Michael Wax, MD
Michael Wax, MD,  Principal Investigator
Vanessa DePaul,  Sub-Investigator

New Mexico
      New Mexico Oncology / Hematology, Albuquerque,  New Mexico,  87109,  United States; Recruiting
Debra Harris, RN  505-243-4039    debrah@nmohc.com 
Richard Giudice, MD
Richard Giudice, MD,  Principal Investigator
Debra Harris, RN,  Sub-Investigator

New York
      HemOnCare, P.C., Brooklyn,  New York,  11235,  United States; Recruiting
Lois Helgeson  718-616-0801    lois.helgeson@impath.com 
Fakhiuddin Ahmed, MD   fahmed2419@aol.com 
Fakhiuddin Ahmed, MD,  Principal Investigator
Lois Helgeson,  Sub-Investigator

      Upstate NY Cancer Research, Rochester,  New York,  14623,  United States; Recruiting
Sue-Ellen Sahmel, CCRA  585-350-2300    sesahmel@frontiernet.net 
Robert Asbury, MD  585-350-2300 
Robert Asbury, MD,  Principal Investigator
Sue-Ellen Sahmel, CCRA,  Sub-Investigator

      Glens Falls Cancer Center, Glens Falls,  New York,  12801,  United States; Recruiting
Josephine Barilli, RN  518-926-6649 
Orlando Martelo, MD   ojm3136@capital.net 
Orlando Martelo, MD,  Principal Investigator
Josephine Barilli, RN,  Sub-Investigator

      South Shore Hematology-Oncology Associates, Rockville Centre,  New York,  11570,  United States; Recruiting
Jeanne Davy, RN OCN  516-536-1455    jeanne.davy@impath.com 
Ronald Primis, MD
Ronald Primis, MD,  Principal Investigator
Jeanne Davy, RN OCN,  Sub-Investigator

      North Shore - Long Island Jewish Health System, New Hyde Park,  New York,  11040,  United States; Recruiting
Dale Janson, RPA-C MBA  718-470-4408    djanson@lij.edu 
Kanti Rai, MD   rai@lij.edu 
Kanti Rai, MD,  Principal Investigator
Dale Janson, RPA-C MBA,  Sub-Investigator

      New York University, New York,  New York,  10016,  United States; Recruiting
Elena DeFrancisco   peytom01@gcrc.med.nyu.edu 
Ken Takeshita, MD   kt15@nyu.edu 
Ken Takeshita, MD,  Principal Investigator
Elena DeFrancisco,  Sub-Investigator

North Carolina
      Clinworks, Inc, Charlotte,  North Carolina,  United States; Recruiting
Terri Carpenter  704-367-9334    tcarpenter@clinworks.com 
Ronald Butler, MD
Ronald Butler, MD,  Principal Investigator
Terri Carpenter,  Sub-Investigator

Ohio
      Private Practice, Canton,  Ohio,  44718,  United States; Recruiting
Carrie Smith  330-492-3345  Ext. 208    gabrailoffice@aol.com 
Nashat Gabrail, MD   ngabrailmd@aol.com 
Nashat Gabrail, MD,  Principal Investigator
Carrie Smith,  Sub-Investigator

Pennsylvania
      Lancaster Cancer Center, LTD, Lancaster,  Pennsylvania,  17605,  United States; Recruiting
Barbara Groff  717-291-1313    barbara.groff@impath.com 
H. Peter DeGreen, MD
H. Peter DeGreen, MD,  Principal Investigator
Barbara Groff,  Sub-Investigator

      Blair Medical Associates, Altoona,  Pennsylvania,  16601,  United States; Recruiting
Robin Stern  814-947-6177    robin.stern@impath.com 
Salee Hoffman, MD
Salee Hoffman, MD,  Principal Investigator
Robin Stern,  Sub-Investigator

South Carolina
      Santee Hematology Oncology, Sumter,  South Carolina,  29150,  United States; Recruiting
Sunil Sharma, MD  803-934-8833    sunilrohini@msn.com 
Billy Clowney, MD   santeeoncology@yahoo.com 
Billy Clowney, MD,  Principal Investigator
Sunil Sharma, MD,  Sub-Investigator

Tennessee
      The West Clinic, Memphis,  Tennessee,  38120,  United States; Not yet recruiting
Jeri Ashley  901-683-0055  Ext. 1124    jashley@westclinic.com 
Lee Schwartzberg, MD
Lee Schwartzberg, MD,  Principal Investigator
Jeri Ashley,  Sub-Investigator

Utah
      Central Utah Medical Clinic Hematology-Oncology, Provo,  Utah,  84604,  United States; Recruiting
Yolonda Stock, RN  801-429-8024    ss_provo@imapth.com 
Wendy Breyer, MD
Wendy Breyer, MD,  Principal Investigator
Yolonda Stock, RN,  Sub-Investigator

Wisconsin
      Marshfield Clinic, Marshfield,  Wisconsin,  54449,  United States; Recruiting
Anita Lyrenmann  715-387-5903    lyrenmann.anita@marshfieldclinic.org 
Seth Fagbemi, MD
Seth Fagbemi, MD,  Principal Investigator
Anita Lyrenmann,  Sub-Investigator

      Oncology of Wisconsin, Glendale,  Wisconsin,  53212,  United States; Recruiting
Tammy Leischer  414-906-4400    tleischer@oncofwis.com 
Ronald Hart, MD   rhart@oncofwis.com 
Ronald Hart, MD,  Principal Investigator
Tammy Leischer,  Sub-Investigator

      Rhinelander Regional Medical Group Onc., Rhinelander,  Wisconsin,  54501,  United States; Recruiting
Nancy Carl  715-361-4714    ncarl@shsmh.org 
Dhimant Patel, MD   dpatel@shsmh.org 
Dhimant Patel, MD,  Principal Investigator
Nancy Carl,  Sub-Investigator

More Information

Study ID Numbers:  AZA III 02
Record last reviewed:  May 2003
Record first received:  May 9, 2003
ClinicalTrials.gov Identifier:  NCT00060671
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10
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