check_circleStudy Completed

Lymphoma, Non-Hodgkin

Bayer Identifier:

100389

ClinicalTrials.gov Identifier:

NCT00044551

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of Bay 59-8862 in Patients with Aggressive, Refractory Non-Hodgkin's Lymphoma

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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
February 2002 - July 2003
Phase
Phase 2
Could I Receive a placebo
No
Products
Cytotoxic Taxane (BAY59-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Centre Hospitalier Universitaire Brabois - Vandoeuvre-les-NaVANDOEUVRE-LES-NANCY, 54500, France
Completed
Centre Hospitalier Lyon Sud - Pierre BénitePIERRE BENITE, 69495, France
Terminated
LSU Health Sciences CenterShreveport, 71130-4228, United States
Completed
Rotterdam Cancer InstituteGroene Hilledijk, Netherlands
Completed
Kliniken und Polikliniken der Albert-Ludwigs-UniversitätFreiburg, 79106, Germany
Completed
Kent Oncology CentreMaidstone, ME16 9QQ, United Kingdom
Terminated
North Shore University HospitalManhasset, 11030-3876, United States
Terminated
New York Medical CollegeValhalla, 10595, United States
Completed
Mt. Sinai Comprehensive Cancer CenterMiami Beach, 33140, United States
Completed
Medical College of WisconsinMilwaukee, 53226, United States
Completed
West ClinicMemphis, 38120, United States
Terminated
Cleveland ClinicCleveland, 44195, United States
Terminated
University of Washington Medical CenterSeattle, 98195, United States
Completed
University of ChicagoChicago, 60637, United States
Completed
Cross Cancer InstituteEdmonton, T6G 1Z2, Canada
Completed
Vrije Universiteit Medisch CentrumAMSTERDAM, 1081 HV, Netherlands
Terminated
Montefiore Medical CenterBronx, 10467-2490, United States
Completed
Addenbrookes HospitalCambridge, CB2 0QQ, United Kingdom
Completed
Charité Campus Benjamin FranklinBerlin, 12200, Germany
Completed
Hôtel Dieu - ParisPARIS, 75151, France
Completed
HemOnCare, PCBrooklyn, 11235-3518, United States
Terminated
The Cancer Institute of New JerseyNew Brunswick, 08903-2681, United States
Completed
Upstate Medical UniversitySyracuse, 13210-2399, United States

Trial design

An Open Phase II, Multi Center Trial of BAY 59-8862 in Patients with Aggressive, Refractory Non-Hodgkin's Lymphoma
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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