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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00067730
Collaborator
(none)
7
Enrollment
5
Locations
1
Arm
7
Duration (Months)
1.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Drotrecogin Alfa (activated)
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Safety Evaluation of Xigris Drotrecogin Alfa Activated in Hematopoietic Stem Cell Transplant Patients With Severe Sepsis
Study Start Date :
Mar 1, 2003
Actual Study Completion Date :
Oct 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

24 microgram/kg/hr for 96 hours (+ or - 1 hour)

Drug: Drotrecogin Alfa (activated)
Other Names:
  • LY203638
  • Xigris

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety [10 months]

    Secondary Outcome Measures

    1. Mortality [10 months]

    2. Bleeding incidence [10 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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
    2 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
    3 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
    4 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
    5 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

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00067730
    Other Study ID Numbers:
    • 6416
    • F1K-US-EVCE
    First Posted:
    Aug 27, 2003
    Last Update Posted:
    Dec 7, 2007
    Last Verified:
    Dec 1, 2007
    Additional relevant MeSH terms:
    Infections
    Sepsis
    Hematologic Neoplasms
    Drotrecogin alfa activated

    Study Results

    No Results Posted as of Dec 7, 2007