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| Sponsor: | Cell Therapeutics |
|---|---|
| Information provided by: | Cell Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00060671 |
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma, Follicular Lymphoma, Mixed-Cell, Follicular Lymphoma, Small Cleaved-Cell, Follicular Lymphoma, Low-Grade |
Drug: rituximab Drug: Pixantrone (BBR 2778) |
Phase III |
| 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) |
| Estimated 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:
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 older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Arizona Clinical Research Center | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Sutter Health Western Division Cancer Research Group | |
| Greenbrae, California, United States, 94904 | |
| Kenmar Research Institute | |
| Los Angeles, California, United States, 90057 | |
| United States, Colorado | |
| Rocky Moutain Cancer Center | |
| Denver, Colorado, United States, 80218 | |
| United States, Florida | |
| Pasco, Hernando Oncology Associates, P.A. | |
| New Port Richey, Florida, United States | |
| Ocala Oncology Center | |
| Ocala, Florida, United States, 34474 | |
| Orange Park Cancer Center | |
| Orange Park, Florida, United States, 32073 | |
| United States, Illinois | |
| Edward Cancer Center | |
| Naperville, Illinois, United States, 60540 | |
| University of Chicago Medical Center Hematology / Oncology | |
| Chicago, Illinois, United States, 60637 | |
| Illinois Masonic Cancer Center | |
| Chicago, Illinois, United States, 60657 | |
| United States, Indiana | |
| Hope Center | |
| Terre Haute, Indiana, United States, 47802 | |
| United States, Kentucky | |
| Commonwealth Hematology/Oncology | |
| Danville, Kentucky, United States, 40422 | |
| United States, Massachusetts | |
| New England Hematology / Oncology Associates | |
| Wellesley, Massachusetts, United States, 02481 | |
| United States, Missouri | |
| St. Joseph Oncology | |
| St. Joseph, Missouri, United States, 64507 | |
| St. Johns Mercy Medical Center | |
| St. Louis, Missouri, United States, 63141 | |
| Christian Hospital | |
| St. Louis, Missouri, United States, 63136 | |
| United States, Montana | |
| Hematology - Oncology Centers of N. Rockies | |
| Billings, Montana, United States, 59101 | |
| Great Falls Clinic | |
| Great Falls, Montana, United States, 59405 | |
| United States, New Jersey | |
| Hematology Oncology Associates of NJ | |
| Paramus, New Jersey, United States, 07652 | |
| East Orange VA Medical Center | |
| East Orange, New Jersey, United States, 07018 | |
| Summit Medical Group/Overlook Onc Center | |
| Summit, New Jersey, United States, 07901 | |
| United States, New Mexico | |
| New Mexico Oncology / Hematology | |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
| HemOnCare, P.C. | |
| Brooklyn, New York, United States, 11235 | |
| Upstate NY Cancer Research | |
| Rochester, New York, United States, 14623 | |
| Glens Falls Cancer Center | |
| Glens Falls, New York, United States, 12801 | |
| South Shore Hematology-Oncology Associates | |
| Rockville Centre, New York, United States, 11570 | |
| North Shore - Long Island Jewish Health System | |
| New Hyde Park, New York, United States, 11040 | |
| New York University | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Clinworks, Inc | |
| Charlotte, North Carolina, United States | |
| United States, Ohio | |
| Private Practice | |
| Canton, Ohio, United States, 44718 | |
| United States, Pennsylvania | |
| Lancaster Cancer Center, LTD | |
| Lancaster, Pennsylvania, United States, 17605 | |
| Blair Medical Associates | |
| Altoona, Pennsylvania, United States, 16601 | |
| United States, South Carolina | |
| Santee Hematology Oncology | |
| Sumter, South Carolina, United States, 29150 | |
| United States, Tennessee | |
| The West Clinic | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Utah | |
| Central Utah Medical Clinic Hematology-Oncology | |
| Provo, Utah, United States, 84604 | |
| United States, Wisconsin | |
| Marshfield Clinic | |
| Marshfield, Wisconsin, United States, 54449 | |
| Oncology of Wisconsin | |
| Glendale, Wisconsin, United States, 53212 | |
| Rhinelander Regional Medical Group Onc. | |
| Rhinelander, Wisconsin, United States, 54501 | |
More Information
| Study ID Numbers: | AZA III 02 |
| Study First Received: | May 9, 2003 |
| Last Updated: | October 28, 2005 |
| ClinicalTrials.gov Identifier: | NCT00060671 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Pixantrone BBR 2778 chemotherapy DNA Intercalator Anthracycline Rituximab Rituxan Mabthera |
monoclonal antibody antibody NHL Non-Hodgkin’s lymphoma indolent low grade Novuspharma |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Lymphoma, Follicular |
Pharmacologic Actions Lymphatic Diseases Neoplasms Therapeutic Uses Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
