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

NCT ID: NCT00044551

Last Updated: 2013-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2003-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma, Non-Hodgkin

Keywords

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Taxane Lymphoma Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Taxane (Cytotoxic, BAY59-8862)

Intervention Type DRUG

Daily 1 h infusion every 3 weeks

Interventions

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Taxane (Cytotoxic, BAY59-8862)

Daily 1 h infusion every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Miami Beach, Florida, United States

Site Status

Chicago, Illinois, United States

Site Status

Shreveport, Louisiana, United States

Site Status

New Brunswick, New Jersey, United States

Site Status

Brooklyn, New York, United States

Site Status

Manhasset, New York, United States

Site Status

Syracuse, New York, United States

Site Status

The Bronx, New York, United States

Site Status

Valhalla, New York, United States

Site Status

Cleveland, Ohio, United States

Site Status

Memphis, Tennessee, United States

Site Status

Seattle, Washington, United States

Site Status

Milwaukee, Wisconsin, United States

Site Status

Edmonton, Alberta, Canada

Site Status

Paris, , France

Site Status

Pierre-Bénite, , France

Site Status

Vandœuvre-lès-Nancy, , France

Site Status

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Berlin, State of Berlin, Germany

Site Status

Amsterdam, , Netherlands

Site Status

Groene Hilledijk, , Netherlands

Site Status

Cambridge, Cambridgeshire, United Kingdom

Site Status

Maidstone, Kent, United Kingdom

Site Status

Countries

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United States Canada France Germany Netherlands United Kingdom

Other Identifiers

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100389

Identifier Type: -

Identifier Source: org_study_id