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| Sponsored by: |
Cell Therapeutics |
|---|---|
| Information provided by: | Cell Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00060684 |
Purpose
The aim of this trial is to determine the appropriate dose of pixantrone to be used in this combination and obtain data on the combination's safety and activity profile.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Low-Grade Lymphoma, Small Lymphocytic Lymphoma, Mixed-Cell, Follicular Lymphoma, Small Cleaved-Cell, Follicular |
Drug: Pixantrone (BBR 2778) Drug: fludarabine Drug: dexamethasone Drug: rituximab |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase I Trial of BBR 2778 in Combination With Fludarabine, Dexamethasone and Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma |
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2001 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
The FND-R regimen is commonly used in the treatment of indolent Non-Hodgkin's lymphoma (NHL) and contains the chemotherapy agents mitoxantrone, fludarabine, dexamethasone (a steroid) and the monoclonal antibody rituximab. In this trial we are replacing mitoxantrone with pixantrone, an agent with a similar chemical structure (both agents are DNA intercalators). The trial is being run in patients with relapsed or refractory indolent NHL and aims to define the appropriate dose of pixantrone to be used in this combination, as well as to obtain data on pixantrone's safety and activity profile in combination with these drugs.
This trial is expected to recruit up to 30 patients in the USA. Patients will be treated with the drug combination for up to eight months and then followed closely in the four-week period after the last administration. After that, patients will receive physician check-ups every three months.
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| United States, Arizona | |
| Arizona Clinical Research Center | |
| Tucson, Arizona, United States, 85712 | |
| United States, Maryland | |
| Greater Baltimore Medical Center | |
| Baltimore, Maryland, United States, 21204 | |
| United States, New Mexico | |
| New Mexico Onc/Hem Consultants, Inc. | |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Director: | Scott Stromatt, MD | Cell Therapeutics |
More Information
| Responsible Party: | Cell Therapeutics, Inc. ( Gabriella Camboni, M.D. ) |
| Study ID Numbers: | AZA I-06 |
| Study First Received: | May 9, 2003 |
| Last Updated: | September 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00060684 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Pixantrone BBR 2778 chemotherapy DNA Intercalator mitoxantrone fludarabine dexamethasone Rituximab Rituxan |
Mabthera monoclonal antibody antibody NHL Non-Hodgkin's lymphoma indolent low grade Novuspharma |
|
Antimetabolites Anti-Inflammatory Agents Dexamethasone Leukemia, Lymphoid Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoma, Follicular Antiemetics Hormones Follicular Lymphoma Lymphoma, Small Cleaved-cell, Diffuse Antibodies, Monoclonal Leukemia Lymphoma, Small Cleaved-cell, Follicular |
Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma Dexamethasone acetate Immunoglobulins Immunoproliferative Disorders Antineoplastic Agents, Hormonal Rituximab Fludarabine monophosphate Immunosuppressive Agents Glucocorticoids Lymphatic Diseases Chronic Lymphocytic Leukemia Antibodies Fludarabine Mitoxantrone |
|
Antimetabolites Anti-Inflammatory Agents Dexamethasone Leukemia, Lymphoid Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoma, Follicular Antiemetics Hormones Leukemia Leukemia, Lymphocytic, Chronic, B-Cell |
Therapeutic Uses Lymphoma Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Rituximab Gastrointestinal Agents Fludarabine monophosphate Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Lymphatic Diseases Neoplasms |
