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



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

For Condition: Lymphoma, Mixed-Cell, Follicular,Lymphoma, Small Cleaved-Cell, Follicular,Lymphoma, Follicular,Lymphoma, Low-Grade
Status: Recruiting
Sponsor(s): Novuspharma ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - Patients with relapsed or refractory indolent non-Hodgkin’s lymphoma (NHL), including follicular lymphoma grade I and II - Presenting with an episode of progressive disease, following 1-5 prior treatments (with either radiation, chemotherapy or rituximab). Exclusion criteria: - Patients that failed to respond to previous rituximab treatment, or relapsed within 6 months of the first rituximab infusion - Patients known to have an allergic reaction to rituximab or murine derived proteins.
Total Enrollment: 800

Location and Contact Information:

New Mexico Oncology / Hematology *Recruiting*
Albuquerque,  New Mexico,  87109
United States
Recruiting Debra  Harris 505-243-4039

Oncology of Wisconsin *Recruiting*
Glendale,  Wisconsin,  53212
United States
Recruiting Tammy  Leischer 414-906-4400

St. Johns Mercy Medical Center *Recruiting*
St. Louis,  Missouri,  63141
United States
Recruiting Christy  Hill 314-569-6933

Hope Center *Recruiting*
Terre Haute,  Indiana,  47802
United States
Recruiting Jacquelyn  Bradfield 812-234-0098

Great Falls Clinic *Recruiting*
Great Falls,  Montana,  59405
United States
Recruiting Bernadette  Mundt 406-452-6657

Hematology - Oncology Centers of N. Rockies *Recruiting*
Billings,  Montana,  59101
United States
Recruiting Mary  Zandt 406-238-6962

Pasco, Hernando Oncology Associates, P.A. *Recruiting*
New Port Richey,  Florida, 
United States
Recruiting Eve  Crosariol 727-842-2795

New York University *Recruiting*
New York City,  New York,  10016
United States
Recruiting Elena  DeFrancisco

Sutter Health Western Division Cancer Research Group *Recruiting*
Greenbrae,  California,  94904
United States
Recruiting Lyssa  Friedman 415-925-7916

Clinworks, Inc *Recruiting*
Charlotte,  North Carolina, 
United States
Recruiting Terri  Carpenter 704-367-9334

Central Utah Medical Clinic Hematology-Oncology *Recruiting*
Provo,  Utah,  84604
United States
Recruiting Yolonda  Stock 801-429-8024

Commonwealth Hematology/Oncology *Recruiting*
Danville,  Kentucky,  40422
United States
Recruiting Julie  Jones 859-236-2203

Glens Falls Cancer Center *Recruiting*
Glen Falls,  New York,  12801
United States
Recruiting Josephine  Barilli 518-926-6649

Hematology Oncology Associates of NJ *Recruiting*
Paramus,  New Jersey,  07652
United States
Recruiting Jessica  Bird 201-634-5353

Rhinelander Regional Medical Group Onc. *Recruiting*
Rhinelander,  Wisconsin,  54501
United States
Recruiting Nancy  Carl 715-361-4714

University of Chicago Medical Center Hematology / Oncology *Not yet recruiting*
Chicago,  Illinois,  60637
United States
Not yet recruiting Kathy  Atwater 773-702-2034

HemOnCare, P.C. *Recruiting*
Brooklyn,  New York,  11235
United States
Recruiting Lois  Helgeson 718-616-0801

Lancaster Cancer Center, LTD *Recruiting*
Lancaster,  Pennsylvania,  17605
United States
Recruiting Barbara  Groff 717-291-1313

Illinois Masonic Cancer Center *Not yet recruiting*
Chicago,  Illinois,  60657
United States
Not yet recruiting Ken  Ziganto 773-296-5360

North Shore - Long Island Jewish Health System *Recruiting*
New Hyde Park,  New York,  11040
United States
Recruiting Dale  Janson 718-470-4408

Orange Park Cancer Center *Recruiting*
Orange Park,  Florida,  32073
United States
Recruiting Carla  Malott 904-272-3139

Arizona Clinical Research Center *Not yet recruiting*
Tucson,  Arizona,  85712
United States
Not yet recruiting Patricia  Plezia 520-290-2510

Kenmar Research Institute *Recruiting*
Los Angeles,  California,  90057
United States
Recruiting Anne  Kennedy 213-386-1888

Marshfield Clinic *Recruiting*
Marshfield,  Wisconsin,  54449
United States
Recruiting Anita  Lyrenmann 715-387-5903

East Orange VA Medical Center *Recruiting*
East Orange,  New Jersey,  07018
United States
Recruiting Xianwen  Qiau 973-395-7087

Edward Cancer Center *Recruiting*
Naperville,  Illinois,  60540
United States
Recruiting Kathy  Seymour 630-527-3787

Private Practice *Recruiting*
Canton,  Ohio,  44718
United States
Recruiting Carrie  Smith 330-492-3345

The West Clinic *Not yet recruiting*
Memphis,  Tennessee,  38120
United States
Not yet recruiting Jeri  Ashley 901-683-0055

Ocala Oncology Center *Recruiting*
Ocala,  Florida,  34474
United States
Recruiting Renee  Genther 352-732-4938

Blair Medical Associates *Recruiting*
Altoona,  Pennsylvania,  16601
United States
Recruiting Robin  Stern 814-947-6177

South Shore Hematology-Oncology Associates *Recruiting*
Rockville Centre,  New York,  11570
United States
Recruiting Jeanne  Davy 516-536-1455

Christian Hospital *Recruiting*
St. Louis,  Missouri,  63136
United States
Recruiting Hellen  Mullner 314-355-5597

New England Hematology / Oncology Associates *Recruiting*
Wellesley,  Massachusetts,  02481
United States
Recruiting Eileen  Capstraw 781-237-5591

Summit Medical Group/Overlook Onc Center *Recruiting*
Summit,  New Jersey,  07901
United States
Recruiting Vanessa  DePaul 908-273-4300

Santee Hematology Oncology *Recruiting*
Sumter,  South Carolina,  29150
United States
Recruiting Sunil  Sharma 803-934-8833

Rocky Moutain Cancer Center *Not yet recruiting*
Denver,  Colorado,  80218
United States
Not yet recruiting Joni  Newman 303-388-4876

Upstate NY Cancer Research *Recruiting*
Rochester,  New York,  14623
United States
Recruiting Sue-Ellen  Sahmel 585-350-2300

St. Joseph Oncology *Recruiting*
St. Joseph,  Missouri,  64507
United States
Recruiting Bob  Moore 816-271-1032


Additional Information:
Study ID Numbers:
  AZA III 02; 
Study Start Date: 
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060671

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