Trial Condition(s):

Lymphoma, Non-Hodgkin

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

Bayer Identifier:

100389

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial 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.

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

Trial Summary

Enrollment Goal
29
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
N/A
Accepts Healthy Volunteers
No

Where to Participate

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Investigative Site

VANDOEUVRE-LES-NANCY, France, 54500

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PIERRE BENITE, France, 69495

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Shreveport, United States, 71130-4228

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Groene Hilledijk, Netherlands

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Freiburg, Germany, 79106

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Maidstone, United Kingdom, ME16 9QQ

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Manhasset, United States, 11030-3876

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Valhalla, United States, 10595

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Miami Beach, United States, 33140

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Milwaukee, United States, 53226

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Memphis, United States, 38120

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Cleveland, United States, 44195

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Seattle, United States, 98195

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Chicago, United States, 60637

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Edmonton, Canada, T6G 1Z2

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AMSTERDAM, Netherlands, 1081 HV

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Bronx, United States, 10467-2490

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Cambridge, United Kingdom, CB2 0QQ

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Berlin, Germany, 12200

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PARIS, France, 75151

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Brooklyn, United States, 11235-3518

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New Brunswick, United States, 08903-2681

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Investigative Site

Syracuse, United States, 13210-2399

For details, please refer to trial results

Additional Information