NCT00067730

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_4 sepsis

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_4 sepsis

Geographic Reach
1 country

5 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

March 1, 2003

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2003

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
Last Updated

December 7, 2007

Status Verified

December 1, 2007

First QC Date

August 25, 2003

Last Update Submit

December 3, 2007

Conditions

SepsisHematologic NeoplasmsHematopoietic Stem Cell TransplantationInfection

Outcome Measures

Primary Outcomes (1)

  • Safety

    10 months

Secondary Outcomes (2)

  • Mortality

    10 months

  • Bleeding incidence

    10 months

Study Arms (1)

1

EXPERIMENTAL

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

Drug: Drotrecogin Alfa (activated)

Interventions

Drotrecogin Alfa (activated)DRUG
Also known as: LY203638, Xigris
1

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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.

Denver, Colorado, United States

Location

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

Location

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

Location

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

Location

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

Location

Related Links

MeSH Terms

Conditions

SepsisHematologic NeoplasmsInfections

Interventions

drotrecogin alfa activated

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 25, 2003

First Posted

August 27, 2003

Study Start

March 1, 2003

Study Completion

October 1, 2003

Last Updated

December 7, 2007

Record last verified: 2007-12

Locations

US(5)