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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
AZA III 02
NCT00060671
January 2005
January 2006
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 |