NCT00044551

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2002

Shorter than P25 for phase_2

Geographic Reach
6 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2002

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2002

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
Last Updated

October 14, 2013

Status Verified

October 1, 2013

First QC Date

August 30, 2002

Last Update Submit

October 10, 2013

Conditions

Lymphoma, Non-Hodgkin

Keywords

TaxaneLymphomaNon-Hodgkin's Lymphoma

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Taxane (Cytotoxic, BAY59-8862)

Interventions

Taxane (Cytotoxic, BAY59-8862)DRUG

Daily 1 h infusion every 3 weeks

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Unknown Facility

Miami Beach, Florida, 33140, United States

Location

Unknown Facility

Chicago, Illinois, 60637, United States

Location

Unknown Facility

Shreveport, Louisiana, 71130-4228, United States

Location

Unknown Facility

New Brunswick, New Jersey, 08903-2681, United States

Location

Unknown Facility

Brooklyn, New York, 11235-3518, United States

Location

Unknown Facility

Manhasset, New York, 11030-3876, United States

Location

Unknown Facility

Syracuse, New York, 13210-2399, United States

Location

Unknown Facility

The Bronx, New York, 10467-2490, United States

Location

Unknown Facility

Valhalla, New York, 10595, United States

Location

Unknown Facility

Cleveland, Ohio, 44195, United States

Location

Unknown Facility

Memphis, Tennessee, 38120, United States

Location

Unknown Facility

Seattle, Washington, 98195, United States

Location

Unknown Facility

Milwaukee, Wisconsin, 53226, United States

Location

Unknown Facility

Edmonton, Alberta, T6G 1Z2, Canada

Location

Unknown Facility

Paris, 75151, France

Location

Unknown Facility

Pierre-Bénite, 69495, France

Location

Unknown Facility

Vandœuvre-lès-Nancy, 54500, France

Location

Unknown Facility

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Unknown Facility

Berlin, State of Berlin, 12200, Germany

Location

Unknown Facility

Amsterdam, 1081 HV, Netherlands

Location

Unknown Facility

Groene Hilledijk, Netherlands

Location

Unknown Facility

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Unknown Facility

Maidstone, Kent, ME16 9QQ, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma

Interventions

taxaneCytotoxinsIDN 5109

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

NoxaeToxic ActionsChemical Actions and Uses

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2002

First Posted

September 4, 2002

Study Start

February 1, 2002

Study Completion

July 1, 2003

Last Updated

October 14, 2013

Record last verified: 2013-10

Locations

FR(3)DE(2)US(13)CA(1)NL(2)GB(2)