- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00044551
Evaluation of Bay 59-8862 in Patients With Aggressive, Refractory Non-Hodgkin's Lymphoma
October 10, 2013 updated by: Bayer
An Open Phase II, Multi Center Trial of BAY 59-8862 in Patients With Aggressive, Refractory Non-Hodgkin's Lymphoma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
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Paris, France, 75151
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Pierre Benite, France, 69495
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Vandoeuvre-les-nancy, France, 54500
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Berlin, Germany, 12200
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Baden-Württemberg
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Freiburg, Baden-Württemberg, Germany, 79106
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Amsterdam, Netherlands, 1081 HV
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Groene Hilledijk, Netherlands
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Cambridgeshire
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Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
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Kent
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Maidstone, Kent, United Kingdom, ME16 9QQ
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Florida
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Miami Beach, Florida, United States, 33140
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Illinois
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Chicago, Illinois, United States, 60637
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Louisiana
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Shreveport, Louisiana, United States, 71130-4228
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New Jersey
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New Brunswick, New Jersey, United States, 08903-2681
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New York
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Bronx, New York, United States, 10467-2490
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Brooklyn, New York, United States, 11235-3518
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Manhasset, New York, United States, 11030-3876
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Syracuse, New York, United States, 13210-2399
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Valhalla, New York, United States, 10595
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Ohio
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Cleveland, Ohio, United States, 44195
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Tennessee
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Memphis, Tennessee, United States, 38120
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Washington
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Seattle, Washington, United States, 98195
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm 1
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Daily 1 h infusion every 3 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2002
Study Completion (Actual)
July 1, 2003
Study Registration Dates
First Submitted
August 30, 2002
First Submitted That Met QC Criteria
September 3, 2002
First Posted (Estimate)
September 4, 2002
Study Record Updates
Last Update Posted (Estimate)
October 14, 2013
Last Update Submitted That Met QC Criteria
October 10, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100389
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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