A Safety Evaluation of Drotrecogin Alfa (Activated) in Patients With Blood Cancer, Severe Infection Related to Bone Marrow Transplantation

This study has been completed.

First Received: August 25, 2003 Last Updated: December 3, 2007 History of Changes

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00067730

Purpose

The purpose is to determine how Drotrecogin Alfa (activated) will affect patients with blood cancers who develop severe sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT).

Condition	Intervention	Phase
Sepsis Hematologic Neoplasms Hematopoietic Stem Cell Transplantation Infection	Drug: Drotrecogin Alfa (activated)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Safety Evaluation of Xigris Drotrecogin Alfa Activated in Hematopoietic Stem Cell Transplant Patients With Severe Sepsis

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation Cancer Sepsis

Drug Information available for: Drotrecogin alfa

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Safety [ Time Frame: 10 months ]

Secondary Outcome Measures:

Mortality [ Time Frame: 10 months ]
Bleeding incidence [ Time Frame: 10 months ]

Enrollment:	7
Study Start Date:	March 2003
Study Completion Date:	October 2003

Arms	Assigned Interventions
1: Experimental 24 microgram/kg/hr for 96 hours (+ or - 1 hour)	Drug: Drotrecogin Alfa (activated)

Detailed Description:

The purpose of this study is to determine how Drotrecogin Alfa (activated) will affect leukemia, lymphoma and myeloma patients who develop sever sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT). The study will evaluate the safety of Xigris by assessing the risk of serious bleeding events, including bleeding within the brain and serious bleeding leading to death.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participants must have Leukemia, Lymphoma or Myeloma.
Participants must have had hematopoietic stem cell transplantation(HSCT) within the past 60 days.
Participants must have infection with either vasopressor dependent septic shock or ventilator-dependent respiratory failure.
Participants must be on a breathing machine or require medication to maintain their blood pressure.

Exclusion Criteria:

Participants must not have increased bleeding risk due to medical conditions or medications.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067730

Locations

United States, Colorado
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Denver, Colorado, United States
United States, Iowa
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Iowa City, Iowa, United States
United States, New York
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Manhassaet, New York, United States
United States, North Carolina
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Winston-Salem, North Carolina, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Durham, North Carolina, United States

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	6416, F1K-US-EVCE
Study First Received:	August 25, 2003
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00067730 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Drotrecogin alfa activated
Fibrin Modulating Agents
Sepsis
Anticoagulants
Protein C

Hematologic Neoplasms
Hematologic Diseases
Fibrinolytic Agents
Cardiovascular Agents
Inflammation

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Communicable Diseases
Drotrecogin alfa activated
Anti-Infective Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Neoplasms
Hematologic Diseases
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents

Infection
Pharmacologic Actions
Inflammation
Fibrin Modulating Agents
Sepsis
Neoplasms
Pathologic Processes
Neoplasms by Site
Protein C
Therapeutic Uses

ClinicalTrials.gov processed this record on July 02, 2009