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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00044551 |
Purpose
Almost two-thirds of lymphoma cases are Non-Hodgkin's Lymphomas (NHL). NHL is a malignant process that affects lymphoid cells found both in the lymph nodes and extranodally. Incidence and mortality rates from NHL are highest in developed countries. While many patients with aggressive NHL are curable with initial anthracycline-containing regimens, the majority of patients will relapse or prove refractory to initial therapy. The prognosis of patients with disease recurrence following a multidrug regimen is also limited. The current protocol is designed to test the safety and efficacy of BAY 59-8862 in patients with Aggressive Refractory Non-Hodgkin's Lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Non-Hodgkin |
Drug: Taxane (Cytotoxic, BAY59-8862) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | An Open Phase II, Multi Center Trial of BAY 59-8862 in Patients With Aggressive, Refractory Non-Hodgkin's Lymphoma |
| Enrollment: | 29 |
| Study Start Date: | February 2002 |
| Study Completion Date: | July 2003 |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Experimental |
Drug: Taxane (Cytotoxic, BAY59-8862)
Daily 1 h infusion every 3 weeks
|
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, Florida | |
| Miami Beach, Florida, United States, 33140 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60637 | |
| United States, Louisiana | |
| Shreveport, Louisiana, United States, 71130-4228 | |
| United States, New Jersey | |
| New Brunswick, New Jersey, United States, 08903-2681 | |
| United States, New York | |
| Bronx, New York, United States, 10467-2490 | |
| Brooklyn, New York, United States, 11235-3518 | |
| Manhasset, New York, United States, 11030-3876 | |
| Valhalla, New York, United States, 10595 | |
| Syracuse, New York, United States, 13210-2399 | |
| United States, Ohio | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Tennessee | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Washington | |
| Seattle, Washington, United States, 98195 | |
| United States, Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Canada, Alberta | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| France | |
| VANDOEUVRE-LES-NANCY, France, 54500 | |
| PIERRE BENITE, France, 69495 | |
| PARIS, France, 75151 | |
| Germany | |
| Berlin, Germany, 12200 | |
| Germany, Baden-Württemberg | |
| Freiburg, Baden-Württemberg, Germany, 79106 | |
| Netherlands | |
| AMSTERDAM, Netherlands, 1081 HV | |
| Groene Hilledijk, Netherlands | |
| United Kingdom, Cambridgeshire | |
| Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ | |
| United Kingdom, Kent | |
| Maidstone, Kent, United Kingdom, ME16 9QQ | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
| Study ID Numbers: | 100389 |
| Study First Received: | August 30, 2002 |
| Last Updated: | May 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00044551 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Taxane Lymphoma Non-Hodgkin's Lymphoma |
|
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |