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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)


Phase 3
18 Years
N/A
Not Enrolling
Both
Lymphoma, Follicular, Lymphoma, Mixed-Cell, Follicular, Lymphoma, Small Cleaved-Cell, Follicular, Lymphoma, Low-Grade

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Trial Information

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)


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

AZA III 02

NCT ID:

NCT00060671

Start Date:

January 2005

Completion Date:

January 2006

Related Keywords:

  • Lymphoma, Follicular
  • Lymphoma, Mixed-Cell, Follicular
  • Lymphoma, Small Cleaved-Cell, Follicular
  • Lymphoma, Low-Grade
  • Pixantrone
  • BBR 2778
  • chemotherapy
  • DNA Intercalator
  • Anthracycline
  • Rituximab
  • Rituxan
  • Mabthera
  • monoclonal antibody
  • antibody
  • NHL
  • Non-Hodgkin's lymphoma
  • indolent
  • low grade
  • Novuspharma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

Marshfield Clinic Marshfield, Wisconsin  54449
Sutter Health Western Division Cancer Research Group Greenbrae, California  94904
Great Falls Clinic Great Falls, Montana  59405
Ocala Oncology Center Ocala, Florida  34474
HemOnCare, P.C. Brooklyn, New York  11235
Arizona Clinical Research Center Tucson, Arizona  85712
Hope Center Terre Haute, Indiana  47809
Kenmar Research Institute Los Angeles, California  90057
Santee Hematology Oncology Sumter, South Carolina  29150
Oncology of Wisconsin Glendale, Wisconsin  53212
St. Joseph Oncology St. Joseph, Missouri  64507
Hematology Oncology Associates of NJ Paramus, New Jersey  07652
The West Clinic Memphis, Tennessee  38120
New York University New York, New York  10016
Rocky Moutain Cancer Center Denver, Colorado  80218
Pasco, Hernando Oncology Associates, P.A. New Port Richey, Florida  
Orange Park Cancer Center Orange Park, Florida  32073
Illinois Masonic Cancer Center Chicago, Illinois  60657
University of Chicago Medical Center Hematology / Oncology Chicago, Illinois  60637
Edward Cancer Center Naperville, Illinois  60540
Commonwealth Hematology/Oncology Danville, Kentucky  40422
New England Hematology / Oncology Associates Wellesley, Massachusetts  02481
St. Johns Mercy Medical Center St. Louis, Missouri  63141
Christian Hospital St. Louis, Missouri  63136
Hematology - Oncology Centers of N. Rockies Billings, Montana  59101
East Orange VA Medical Center East Orange, New Jersey  07018
Summit Medical Group/Overlook Onc Center Summit, New Jersey  07901
New Mexico Oncology / Hematology Albuquerque, New Mexico  87109
Glens Falls Cancer Center Glens Falls, New York  12801
North Shore - Long Island Jewish Health System New Hyde Park, New York  11040
Upstate NY Cancer Research Rochester, New York  14623
South Shore Hematology-Oncology Associates Rockville Centre, New York  11570
Clinworks, Inc Charlotte, North Carolina  
Private Practice Canton, Ohio  44718
Blair Medical Associates Altoona, Pennsylvania  16601
Lancaster Cancer Center, LTD Lancaster, Pennsylvania  17605
Central Utah Medical Clinic Hematology-Oncology Provo, Utah  84604
Rhinelander Regional Medical Group Onc. Rhinelander, Wisconsin  54501