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Evaluation of Bay 59-8862 in Patients With Aggressive, Refractory Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00044551
Recruitment Status : Completed
First Posted : September 4, 2002
Last Update Posted : October 14, 2013
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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 or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: Taxane (Cytotoxic, BAY59-8862) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Phase II, Multi Center Trial of BAY 59-8862 in Patients With Aggressive, Refractory Non-Hodgkin's Lymphoma
Study Start Date : February 2002
Actual Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Arm 1 Drug: Taxane (Cytotoxic, BAY59-8862)
Daily 1 h infusion every 3 weeks





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria: - Measurable disease as defined by the presence of at least one measurable lesion - Failed at least one prior therapy or has achieved remission but has progressed or relapsed within 6 months of therapy - Life expectancy of at least 12 weeks - Adequate bone marrow, liver and kidney function Exclusion Criteria: - Excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers - Excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant - Others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044551


Locations
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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
Syracuse, New York, United States, 13210-2399
Valhalla, New York, United States, 10595
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
Paris, France, 75151
Pierre Benite, France, 69495
Vandoeuvre-les-nancy, France, 54500
Germany
Freiburg, Baden-Württemberg, Germany, 79106
Berlin, Germany, 12200
Netherlands
Amsterdam, Netherlands, 1081 HV
Groene Hilledijk, Netherlands
United Kingdom
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Maidstone, Kent, United Kingdom, ME16 9QQ
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00044551    
Other Study ID Numbers: 100389
First Posted: September 4, 2002    Key Record Dates
Last Update Posted: October 14, 2013
Last Verified: October 2013
Keywords provided by Bayer:
Taxane
Lymphoma
Non-Hodgkin's Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Taxane
IDN 5109
Antineoplastic Agents