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CompletedNCT00044551Updated Oct 14, 2013

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

A Phase 2 interventional study of Taxane (Cytotoxic, BAY59-8862) in Lymphoma, Non-Hodgkin, sponsored by Bayer. Completed at 23 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-14.

Sponsored by Bayer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
29
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Lymphoma, Non-Hodgkin

Keywords

  • Taxane
  • Lymphoma
  • Non-Hodgkin's Lymphoma
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In context

Lymphoma, Non-Hodgkin

2,043 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 309 are open to participants now.

This study's enrollment of 29 is below the median of 40 across 1,744 interventional studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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

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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: Taxane (Cytotoxic, BAY59-8862)

Interventions

06

Study locations

23 sites
  • Miami Beach, Florida 33140, United States
  • Chicago, Illinois 60637, United States
  • Shreveport, Louisiana 71130-4228, United States
  • New Brunswick, New Jersey 08903-2681, United States
  • Brooklyn, New York 11235-3518, United States
  • Manhasset, New York 11030-3876, United States
  • Syracuse, New York 13210-2399, United States
  • The Bronx, New York 10467-2490, United States
  • Valhalla, New York 10595, United States
  • Cleveland, Ohio 44195, United States
  • Memphis, Tennessee 38120, United States
  • Seattle, Washington 98195, United States
  • Milwaukee, Wisconsin 53226, United States
  • Edmonton, Alberta T6G 1Z2, Canada
  • Paris, 75151, France
  • Pierre-Bénite, 69495, France
  • Vandœuvre-lès-Nancy, 54500, France
  • Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany
  • Berlin, State of Berlin 12200, Germany
  • Amsterdam, 1081 HV, Netherlands
  • Groene Hilledijk, Netherlands
  • Cambridge, Cambridgeshire CB2 0QQ, United Kingdom
  • Maidstone, Kent ME16 9QQ, United Kingdom
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00044551
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Sep 4, 2002
Start date
Feb 2002
Completion
Jul 2003
Last update
Oct 14, 2013

Study contacts

Bayer Study Director
study director · Bayer
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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