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

Phase 4

Completed

• Conditions: Sepsis; Hematologic Neoplasms; Hematopoietic Stem Cell Transplantation; Infection
• Interventions: Drug: Drotrecogin Alfa (activated)

• Registration Number: NCT00067730
• Lead Sponsor: Eli Lilly and Company

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).

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 Timeline

• Study Start: 2003-03
• Study First Submitted: 2003-08-25
• Study First Submitted QC: 2003-08-26
• Study First Posted: 2003-08-27
• Study Completion: 2003-10
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-03
• Last Update Posted: 2007-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Drotrecogin Alfa (activated)	24 microgram/kg/hr for 96 hours (+ or - 1 hour)

Primary Outcome Measures

Name	Time	Method
Safety	10 months

Secondary Outcome Measures

Name	Time	Method
Mortality	10 months
Bleeding incidence	10 months

Trial Locations

Locations (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.; 🇺🇸 Winston-Salem, North Carolina, United States