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

NCT ID: NCT00044551

Last Updated: 2013-10-14

Basic Information

• 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

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.

Conditions

Lymphoma, Non-Hodgkin

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Taxane (Cytotoxic, BAY59-8862)

Intervention Type: DRUG

Daily 1 h infusion every 3 weeks

Interventions

Taxane (Cytotoxic, BAY59-8862)

Daily 1 h infusion every 3 weeks

Intervention Type: DRUG

Eligibility Criteria

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

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Miami Beach, Florida, United States

Chicago, Illinois, United States

Shreveport, Louisiana, United States

New Brunswick, New Jersey, United States

Brooklyn, New York, United States

Manhasset, New York, United States

Syracuse, New York, United States

The Bronx, New York, United States

Valhalla, New York, United States

Cleveland, Ohio, United States

Memphis, Tennessee, United States

Seattle, Washington, United States

Milwaukee, Wisconsin, United States

Edmonton, Alberta, Canada

Paris, , France

Pierre-Bénite, , France

Vandœuvre-lès-Nancy, , France

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Berlin, State of Berlin, Germany

Amsterdam, , Netherlands

Groene Hilledijk, , Netherlands

Cambridge, Cambridgeshire, United Kingdom

Maidstone, Kent, United Kingdom

Countries

United States; Canada; France; Germany; Netherlands; United Kingdom

Other Identifiers

100389

Identifier Type: -

Identifier Source: org_study_id